Imetelchat - Here’s maybe why we didn’t get priority.

While I do agree that Imetelchat isn't necessarily the board to discuss the SP and any potential manipulation of the SP, it does and has presented itself here from time to time. Geron says the agency also plans to hold an advisory. The modular NDA has been completed, summitted, and has a very, very high probability of being accepted and approved. You agree that “ImetelChat” have the right to remove, edit, move or close any topic at any time should we see fit. Monitoring the health of one's heart and cardiovascular system is one of the most important preventative steps an individual can take to ensure their long-term health. Re: The cost to develop a new drug. Jul 5, 2020 · Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis • Business Wire • 12/06/2023 01:00:00 PM. It’s pretty obvious that the extraordinary manipulation we have seen, not only recently but over the years is in play on some level. Has anyone seen any comments besides the X comments kindly referenced by RC? Usually there is a bunch of video interviews, articles post ASH. A mix of inflation, lingering international travel restrictions in some parts of the world and geopolitical tension in Eastern Europe will keep domestic hotel costs high this summe. Feb 6, 2024 · They were at the Geron table in 2020 (speculation on my part based on the EA hire from Novartis who returned immediately after meetings with the FDA). Once the Public Hearing portion started, I began to make posts (“March 14” thread) as I felt the tide turning. Lekola, that program is very early and I suspect now Geron will slow roll it and keep the focus on approval for IV Imetelstat. Well, hence the cytopenias that are “limited and manageable. Re: Down the road, way down the road. erythropoiesis stimulating agents (ESA). Just the newer classification system that up’s more patients out of lower risk categories and highlights that there is utility in more advanced classifications going forward. Form 8-K - Current report • Edgar (US Regulatory) • 12/15/2023 09:23:51 PM. Madanat’s tweet that says this. When it happens, Imetelstat becomes a factor in all telomere/telomerase (about 90. In the beginning, Erythropoietin seems to work for my mother but now we are back to the same condition, her Hb is dropping in 2-3 months and she needs blood …. Everyone agreed (including the 2 NO ODAC votes) that Transfusion Independence was important. I would add the list one more question. PDUFA date of June 16, 2024 for imetelstat in transfusion-dependent (TD) LR-MDS* MAA review completion expected by end-2024, with potential EU approval and launch in 2025. Geron has added (at expense) many layers of experts including those who specialize in being sure all the FDA t’s are crossed and i’s dotted. Mar 25, 2024 · CHICAGO-- (BUSINESS WIRE) -- MAIA Biotechnology, Inc. Yes Jay, it seems that we have a long and fluid catalogue of board members with experience in buy outs. , June 29, 2023-- (BUSINESS WIRE) --Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company's first-in-class telomerase inhibitor. There has been considerable discussions (some on this board) about Imetelstat and cancer vaccines. The NDA has been summitted, and soon will be accepted and approved. What is a safe level? (benefit vs. info Board index ImetelChat; Search; New article Hat tip to YMB. El idioma oficial del PatientPortal es el inglés. In certain embodiments, the telomerase inhibitor is imetelstat or imetelstat sodium and the Bcl-2 inhibitor is ABT-199. 2 billion in assets under management. In the crosshairs of Geron's development plan was the myelofibrosis market dominated by Incyte's JAK-2 inhibitor, Jakafi. They were at the Geron table in 2020 (speculation on my part based on the EA hire from Novartis who returned immediately after meetings with the FDA). district 214 employment opportunities They all serve different purposes like enabling the animal to survive in seawater below freezing point at the South Pole. Apr 11, 2024 · by Ryan » Thu Apr 11, 2024 6:17 am. Please note that the YouTube live video of the meeting will not broadcast until …. When a person dies, all of his affairs must be settled through an orderly legal process. The new drug application for imetelstat is based on findings from the phase 3 IMerge trial, in which the telomerase inhibitor outperformed placebo in the treatment of …. The concept of a telomerase inhibitor, as an important treatment for most cancers, will have been established in 2024 as a critical breakthrough for the treatment of most. Saturday, December 10, 2022: 2:30 PM. by rccola335 » Fri Mar 15, 2024 2:24 pm. Are you aware of any agent in development or in the clinic the has resulted in. info Board index ImetelChat; Search; Post to Fish Jr. Comments submitted before Feb 29th will be presented to the committee. No negative news at all for the ADCOMs to consider. This was equivalent to a total of around 104,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. Stocks are always halted the day of the advisory committee meeting. , December 21, 2023--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 417,490 shares of Geron common stock as inducements to newly hired employees in …. We are committed to creating broader treatment access solutions, and. 2 I expect an announcement on a European partnership to be announced soon after FDA approval. Apr 6, 2024 · The Applicant is seeking approval of imetelstat (proposed trade name RYTELO) for the treatment of. When you live within your means, you can break the paycheck-to-paycheck. Mar 15, 2024 · The news of J&J terminating its collaboration in Sept 2018 was undoubtedly disheartening. info Board index ImetelChat; Search; More Ash 2022 - check out at 6 min 25 sec. 45 million shares of LCID stock as of Q4, up from 28. Everything for Imetelstat now is phase 3 successful, or in advance clinical studies including 2 ways to kill cancer stem cells. Joined: Thu Jul 14, 2016 2:00 am. Well, hence the cytopenias that are "limited and manageable. by jayfish101 » Thu Feb 22, 2024 10:37 pm. The EAP is in place, MD Anderson continues use and research, and ODAC has accepted the NDA for review. by lacour_98 » Thu Jan 18, 2024 11:28 pm. In the meantime a buyout/partnership conceivably could occur. Listening to the likes of Nick Bostrom, Stuart Russell, Geoffrey Hinton and many others those guardrails, the alignment problem, the clear and unambiguous definitions of objectivesall appear to be so nuanced, and massively complex that the exponential development of these entities will simply bypass …. I like this one: “ Imminenter”. Will check my private emails as I think you have that address. Dylan Supina - Sr Director, Real World Evidence Analytics & Strategy - 2023. The FDA has a built-in argument against exposing these patients to imetelstat’s side effects without evidence of benefit. The LA-based venture firm that Brendan Wallace and Brad Greiwe launched less than seven years ago already has $3. Your resilience, compassion, and commitment to supporting one another are truly inspiring. It’s very slow moving in case you haven’t noticed. “Having this extra weapon in our arsenal would create so much opportunity particularly in combining this drug, and others like it, with existing treatments like chemotherapy and other novel cancer therapies," Professor Lane said. Imetelstat, our novel investigational telomerase inhibitor, binds to telomerase and inhibits its activity, selectively killing the malignant stem and progenitor cells in the bone marrow that are the source of disease in blood cancers, such as myelodysplastic syndromes (MDS) and myelofibrosis (MF). Lisa Meletta - VP, Associate General Counsel, Chief Compliance Officer, Geron Corporation. by biopearl123 » Wed Dec 06, 2023 4:02 pm. Ferroptosis: Ferroptosis is an intracellular iron-dependent form of cell death that is distinct from apoptosis, necrosis, and autophagy. Sergei Gryaznov, now at MAIA)) spent so much time with both companies developing Imetelstat and THIO as important cancer medicines. Jan 30, 2024 · On January 30, 2024, the FDA. Travel was also a major channel of compensation, with cumulative payments of $684,622. Great post that sums up the way I feel too. I think we'll see an early readout on the Investigator led IMPress HR-MDS/AML trial before we hear anything on Imet 2. , June 20, 2023--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the submission to the United States Food and Drug. They didn’t come up with this themselves. So wonderful to see Claudia’s youthful crackling intelligence and enthusiasm and Steven’s gravitas. by biopearl123 » Tue Nov 28, 2023 4:19 pm. randall tex cobb today There is a lot to be learned here not only in terms of the science of the CD47 pathway, but also in terms of trial design, endpoints, & overall drug development approach. Importantly, 61 of these are currently in the regulatory phase, pending decisions from the FDA. The IP address of all posts are recorded to aid in enforcing these conditions. The FDA, other biotechs, Big Pharma, medical and scientific advancements all fall under that umbrella. The PPS will soon be in double digits. I believe they are focusing on a combination for non-small-cell lung cancer with Regeneron. Go over to Imetelchat and read Kmall's 6 part series, "Go Big Or Go Home" for a detailed breakdown of patient in-discrepancies and market potential with actual links provided of data compiled. History Lesson: Imetelstat (IMET has come a long way since ET). MDS foundation - first post I read. Browse our rankings to partner with award-winning experts that will bring your vision to life. Geron is so into inducing, the deduction I make is I too am induced. It did cross my mind that the delay here could be tied to an early approval on AML since it's mentioned with MDS by both Regulatory Agencies. As shareholders let's all hope we get a partnership at some point in the very near future. 2 days ago · In total there are 23 users online :: 0 registered, 0 hidden and 23 guests (based on users active over the past 5 minutes) Most users ever online was 379 on Thu Jul 29, 2021 4:50 am. Geron is focused on blood cancers and has not had a chance to think very much about solid tumor cancers. They've been direct and forthcoming, and …. info Board index ImetelChat; Search; Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat. Also learn about compounding and inflation! The College Investor Student Loans, Investing, B. by biopearl123 » Sun Aug 27, 2023 10:31 pm. And of course to John and his team who had the vision to see this through to this point. best great buildings forge of empires I do expect some significant collaborations or partnerships to accelerate the manufacturing, distribution and sales of Imetelstat. Username: Password: I forgot my password. In total there are 16 users online :: 0 registered, 0 hidden and 16 guests (based on users active over the past 5 minutes) Most users ever online was 379 on Thu Jul 29, 2021 4:50 am. This is the door to all future projects involving Imetelstat. Jun 2015 - Jun 2019 4 yrs 1 mo. GERN has a market cap of $334mn and a cash reserve of $215mn. Last post by huntingonthebluffs. The company's New Drug Application (NDA) for Imetelstat, …. A textbook example of how to anticipate, prepare, and deliver under …. syndromes (MDS) who have failed to respond, or have lost response to, or are ineligible for. Former employers: Novartis, GlaxoSmithkline. Playboy News: This is the News-site for the company Playboy on Markets Insider Indices Commodities Currencies Stocks. Presenting for Geron at FDA Thursday. If approved, imetelstat will enter an evolving MDS market, with its main rival considered to be Bristol-Myers Squibb's erythroid maturation agent Reblozyl …. This was equivalent to a total of around 104,000 people*, and is below the ceiling for orphan designation, which is 5 …. provided notice in the Federal Register that it has scheduled an advisory committee meeting of the Oncologic Drugs Advisory Committee as part of the NDA. by Ryan » Tue Mar 12, 2024 1:16 am. by Ryan » Tue Mar 19, 2024 2:58 am. Our KOL's have met this head on and reassured that they have plenty of experience handling these issues and of course they do as Dr. This section provides you with an archive of past and present …. That would be wonderful news & opportunity for us. used disc harrow for sale craigslist Off-label uses will come into focus. by KTArsenal » Fri Mar 15, 2024 12:15 am. Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. It excels in overall survival time, disease modification, safety profile, transfusion independence, and …. FYI for this October event, doubtful we’ll have the ability to view, or receive any video, transcript or notes for the meeting. we are close to finally, finally proving, and being validated as, a life saving drug: Comment. Hi Saltrock and thanks for posting. So I say, it’s so nice post it twice. Geron (NASDAQ:GERN) is a Nasdaq-listed biotech that has been around a long time - its IPO took place in 1996 at $8 per share, although the. I'm also not aware if we're somewhat …. The system doesn't allow me to post there anymore so I decided to share my thoughts with you. Imetelchat, for me, has been a wonderful, educational tool to learn about the process of CTs, how to understand many CT data, and the inner-workings of a biotech business. CHECK THE APPROPRIATE [LINE] IF A MEMBER OF A GROUP. MAIA Biotechnology Announces Share Purchase by Director Stan Smith, PhD in a $2. Gryzanov invented Imetelchat at Geron and a variation (THIO) at MAIA, where he is now. by biopearl123 » Sun Dec 17, 2023 6:16 pm. Nov 14, 2023 · Today the EMA Approves Modification to Imetelstat PIP. land for sale west by LWS » Wed Mar 20, 2024 5:39 pm. Comments after that date will be taken into consideration by the FDA. This appears to be true: 1/ Telomerase inhibition is an important factor is treating most cancers, and in combinations has the potential for cures. used callaway rogue My guesstimate is Geron is at about $1. So I say, it's so nice post it twice. The Price Per Share (PPS) will be the focus for a while. I may be naive (oh, really) by biopearl123 » Tue Jan 30, 2024 8:09 pm. Scarlett stated that they contracted experts to prepare for and practice for the meeting. Oct 16, 2023 · Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. The PM function on chat can be unwieldy. 26, 2024) There were no Hy's Law cases. Negotiated multi-million dollar settlements representing the U. Geron Corporation Message board - Online Community of active, educated investors researching and discussing Geron Corporation Stocks. The development of imetelstat is grounded on Nobel Prize-winning scientific discoveries by early Geron collaborators that expanded the understanding of telomeres and telomerase and their role in the proliferation of cancer cells. Discover the best graphic design consultant in Washington DC. Whatever the truth behind the JnJ discontinuation, the facts and data support that they must surely still have some level of interest in Imetelstat, which is proving to be much more promising, impactful and lucrative than they originally thought back then. (RTTNews) - Chipotle Mexican Grill Inc. Feller was an easy choice to replace Dr. Bp - Correct, however, pre-market it had traded just under 25million shares, and was up substantially intra-day, like 30-40%. I just read the FDA briefing doc and have a lot of questions regarding the data. by kmall » Tue Oct 10, 2023 3:24 am. Looks like they are back on board. Imetelstat, a first-in-class telomerase inhibitor, demonstrated meaningful clinical benefit including a robust symptom response rate and potential overall survival …. I think we have to remember how COVID dreadfully set back enrollment in many studies. 3) Patients who realized a meaningful increase in their hemoglobin levels. You can expect to see a few Discussion Questions, which will be the focus of the ADCOM meeting. 1 Replies 265 Views Last post by LWS Wed Apr 17, 2024 7:43 pm RYTELO « by huntingonthebluffs » Sat Apr 06, 2024 8:34 pm » in ImetelChat. Together, we continue to advocate for progress and hold onto the belief that …. Forum rules - Comments must be civil and on topic. Dec 2, 2023 · Imetelstat---It all seems to be tied together in one important cancer treatment package, that may lead to cancer cures (TBD by many years of research) --- transfusion independence, disease modification, telomerase, telomeres, ferroptosis, feeling better (fatigue, quality of life, etc. The Oncology ADCOM needs to be put on the schedule for Imetelstat (probably after ASH2023) post haste. complex biologics have been gaining in popularity. , June 29, 2023-- (BUSINESS WIRE) --Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor. I also imagine s/he does not feel great by day 6 after infusion. The discussion has come down to the scheduling of the Oncology ADCOM meeting featuring Imetelstat and John Scarlett's views on the business going forward …. QT interval disorders and specifically "Torsades de Pointes" are of particular interest to EPs. As you can see on clin trials site, there have been many solid tumor studies from over a decade ago that failed. Wow, when somebody writes “my life depends on it”, it gives you pause and makes you realize the gravity of this decision. I believe we can finally concentrate on the PPS. Re: "Next Generation TI Program". Imetelstat kills cancer stem-cells in 2 ways and is needed now by suffering patients. I didn't realize that even though Imetelstat works better on RS- than RS+, the RS- population outnumber RS+ about 3-1. Feb 23, 2022 · GERN has a market cap of $334mn and a cash reserve of $215mn. info Board index ImetelChat; Search; another article. Rizo, it's COMPLETELY apparent that Dr. Kmall, I was amazed at your numbers from several years ago, thinking them perhaps too optimistic. Staying in the same job for decades is a thing of the past. I think the subtext is that there is hope that progression to high risk and AML may be attenuated (and if so. From Imetechat - "Go Big Or Go Home - Pt. Get ratings and reviews for the top 12 gutter guard companies in Maryland City, MD. Big implications for Imetelstat. , (NYSE American: MAIA) (“MAIA,” the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent director Mr. To this end, the company itself and numerous other sponsors have, for years, been testing ruxolitinib combinations. I believe we are close to $4 PPS, and moving higher. by biopearl123 » Tue Feb 20, 2024 4:09 pm. by rccola335 » Sat Mar 16, 2024 1:12 pm. This will be of interest to potential partners and collaborators. Get ratings and reviews for the top 11 gutter companies in Rose Hill, VA. If you have ever owned a garage, you have likely experienced a garage door that either tries to lift on its own or wants to slowly fall to the floor. Jose 8m ago "It is very frustrating to witness the constant selling pressure in Geron stock. 5 days ago · ODAC recommends (12 YES votes from blood cancer experts, 2 No votes) and the FDA approves. Great dig, hope some on board can listen in and report back. As I recall the end point was ORR. We know exactly what will happen. Geron Corporation has added a new press release to its website: Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635 (c) (4) Click here for a complete listing of Geron Corporation press releases. i was thinking the same thing - i believe Oct 25 was the deadline for submission - I would like to know the response from the lady in the news report, she sure seems happy with imetelstat. by biopearl123 » Fri May 26, 2023 2:32 am. Two units every 7-10 days, that’s difficult. Patient #9 was put on Luspatercept in Jun'22. Jan 10, 2024 · Imetelstat is a first-in class telomerase inhibitor for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). Eighteen months ago, I posted a multi-series post titled “Go Big or Go Home” here on Imetelchat. His “article” (blog) is nothing but more gaseous click bait. He emphasizes the neutropenia and thrombocytopenia as potential problems. The fight to white out the black box. I can somewhat understand the attack dog mentality of the FDA rep as Imetelstat is a first in class novel drug never before approved for any indication. These cells must die to allow for recovery of normal cells that can repopulate the bone marrow. Imetelstat is worth quite a bit more than $2. 3 days ago · Ryan, you are always teaching me new words. by biopearl123 » Sat Mar 16, 2024 6:46 am. Former employers: Ipsen, Amgen, Roche, Bristol-Meyers Squibb, Organogenesis. Helping you find the best gutter guard companies for the job. I will try to post my thoughts & observations prior to the upcoming Q4 & 2022. by LWS » Fri Dec 01, 2023 7:22 pm. Sometimes there will be pre-market and post-market trading. Perhaps it could be used in true combination, sequentially, or afterwards to help minimize the cancer developing a resistance to the primary chemo treatment. Check out some Labor Day activities for kids that will keep you active on Labor Day. Two patients had both post baseline elevated bilirubin > 2 x ULN and ALT≥ 3 x ULN, i. , June 29, 2023--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for. AML study PII results will probably not be known until a scientific meeting. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. by CKTC » Fri Mar 15, 2024 12:55 pm. Biopearl Kmall Thanks for all the hard work you've done to keep imetelchat positive, relevant, and fact-based. provided notice in the Federal Register that it has scheduled an advisory committee meeting of the Oncologic Drugs Advisory Committee as part of …. Thanks for posting Jayfish, considering we have heard plenty from KOLs already, virtually all of which has been positive, I think an ADCOM is a positive event and will give voice to patient advocates, patients and physicians. by LWS » Wed Mar 27, 2024 12:08 am. As you state, 30% of the patients have to die in order to trigger the first data look. And Geron should, or another company will. In the crosshairs of Geron’s development plan was the myelofibrosis market dominated by Incyte’s JAK-2 inhibitor, Jakafi. Mar 1, 2024 · Namebackwards could've been writing on Twitter and imetelchat from a local library or somewhere else with a common IP address. 6 days ago · Welcome to the website for the Geron Securities Litigation. maria mccool calista husband info Board index ImetelChat; Search; FDA and CAR-T. by LWS » Wed Sep 20, 2023 12:41 am. While my topic may skirt the fringes in some folks opinions here, it is affected by the FDA. Instead by garnering second line approval which seems highly likely, their. A textbook example of how to anticipate, prepare, and deliver under extreme. Wow, when somebody writes "my life depends on it", it gives you pause and makes you realize the gravity of this decision. by kmall » Thu Jan 11, 2024 12:45 pm. Comments made to the effect that Imetelstat is in a "different space" and the goal is to prolong life and improve the bone marrow picture. They have a lot of power and with that. March 14, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC) Webcast Information The Center for Drug Evaluation and Research (CDER) plans to hold the March 14, 2024, meeting of the Oncologic Drugs Advisory Committee virtually via YouTube platform. The FDA rep was intelligent and very data literate…. Jolinda Schulte - Regional Business. As previously disclosed, in August 2023, Geron Corporation (“Geron” or the “Company”) announced that its New Drug Application (“NDA”) for the. He doesn't comment specifically on his experience with Luspatercept, but he was enrolling in the Imetelstat trial in May'23 (~11 months later). I like this one: " Imminenter". 13 that it achieved encouraging results when it turned its vaccine technology against cancer. I don't have any further details other than the link I provided in the 3rd post of this topic chain which opens the official EMA document which sanctions and approves the investigatory use of Imetelstat in children between the ages of 28 days and 18 years with MDS, JMML, and AML. Luspatercept , as CKTC has pointed out is in the "sweet spot" but pretty soon three questions will be asked of Imetelstat: 1. Garcia-Manero said the disproportionate number of patients with ring sideroblasts was the result of the more common occurrence of this phenotype and the approval of luspatercept in ring sideroblast–positive patients. Re: We are now a little over a month from top line data release. by LWS » Mon Mar 04, 2024 11:07 pm. Previous for reference: Imetelstat is a miracle blood cancer medicine that uniquely modifies that group of diseases, kills cancer stem cells (in 2 ways), brings about transfusion independence, and will effectively treat (PRs, CRs, possible cures) some cancers in combinations. 30 per share that came off the stock price last week as they were selling the new shares (open market). Scarlett has traditionally used the expression, "watch this space" and I always took that to mean, 'watch what we do, not …. “To be considered for Priority Review, a drug must address a serious condition and. With all of the handcuffs placed on docs these days (read "you need prior authorization for that") the fight to let doctors be doctors is valid and valuable. Forum rules - Comments must be civil and on topic - Back up claims with evidence/reasoning/sources (posting links is allowed). Re: This is a big deal- a convert. It’s been a year since one of the world’s bigg. by Hoosier Investor » Tue Mar 12, 2024 6:02 pm. By using an extensive criterion that includes virtually all adult cardiovascular disorders they want to isolate any potential effect on the QT interval. Feller 1/Imetelstat (for ET) was completely successful with CRs and Cures (all completed by Geron), but that was not sufficiently financially feasible then (at Geron with Dr. If my recollection serves, it was around the time of the NEJM Tefferi article. Helping you find the best gutter companies for the job. aggregated amount beneficially owned by each reporting person. Namebackwards could've been writing on Twitter and imetelchat from a local library or somewhere else with a common IP address. A new drug application (NDA) for imetelstat, a telomerase inhibitor used to treat transfusion-dependent anemia in patients with low- to intermediate-1-risk myelodysplastic syndromes (MDS), has been submitted to the FDA, according to a recent press release from Geron Corporation. For some unknown reason they walked. The alternatives are difficult to find. Re: Finally, disease modification? by Ryan » Mon Mar 11, 2024 7:54 pm. I also became a patron of imetelchat. The name and details of the European partner have the potential to move the price significantly - I think the FDA and European …. This data is important for some obvious & non-obvious reasons, and I'm optimistic they'll be able to identify a protocol involving the combination of TI + JAK inhibitors. The End Game: The NDA has been summitted to the FDA, with all (i's) dotted and (t's) crossed. The meeting will be open to the public. Re: Request for Imetelchat Board thoughts. info Board index ImetelChat; Search; meanwhile, back on topic. Morial Convention Center) Claudia Bruedigam, PhD1. For more information, visit www. Re: A blessing from the hepatologists Major hat tip to Wildrides YMB. Rizo will keep her unvested stock options going forward. The BMJ analysis also found that industry paid nearly $1. Is it possible that at some point with a significant patient. by LWS » Sun Jan 28, 2024 6:46 pm. Joined: Sat Sep 28, 2019 10:00 pm. So with those projections in mind, and Anil Kapur's estimates on the number of patients that Imetelstat could treat vs. sole dispositive power 0 shares 8. transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic. I don't see any problem for 6-thio-dG, but would like to hear any ideas on it. Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation Barcelona, Spain Aug 2020 - Present 2 yrs 4 mos. by Hoosier Investor » Thu Mar 14, 2024 9:49 pm. made an individual purchase of 170,940 shares of the Company's common stock. Excerpts from NCI---for review Off-label drug use refers to the practice of prescribing a drug for a different purpose than what the FDA approved. RISK: * A patient who experiences a Grade 3/4 event WITHOUT realizing an improvement in their A) transfusion frequency, B) transfusion burden, or C) Hemoglobin levels. by LWS » Wed Nov 01, 2023 5:18 pm. I've not once felt that biopearl or kmall have echo-chambered this educational message board to pump Geron or imetelstat. Re: A note from your board moderator. boxer puppies for sale under $300 dollars near me "My mother’s is diagnosed for Myelodysplastic syndrome (MDS) and Erythropoietin was the treatment. by biopearl123 » Thu Dec 28, 2023 12:11 am. Update for TMAC recruitment of P3 IMpact in Europe 1/27/2023: Italy-Arcispedale S Maria Nuova, AO di Reggio Emilia - Reggio Calabria, Italy, 42123 - Now Recruiting. Increased Offer! Hilton No Annual Fee 70K + Free Night Cert Offer! American Airlines and the Anguilla Tourist Board have announced that starting April 2, 2022, the carrier will beg. Unnecessary disease in those that did not benefit. Re: Everyone catch this one last night? by LWS » Mon Feb 12, 2024 4:12 pm. The company's New Drug Application (NDA) for Imetelstat, specifically for. 9 Million Private Placement March 22, 2024 3:00 PM EDT Tweet Share E-mail. Doing so may lead to you being immediately and permanently banned, with notification of your Internet Service Provider if deemed required by us. Let’s start with the side effects of blood transfusions: 1. Syros Pharmaceuticals (NASDAQ: SYRS) announced initial data from its Phase 2 SELECT-AML-1 trial evaluating tamibarotene with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression. Feller was a rock star at the ODAC meeting. Did not see a mention of NEA though. The board administrator may also grant additional permissions to registered users. why do I feel like there was a lot of manipulation today that benefited certain people. It's pretty obvious that the extraordinary manipulation we have seen, not only recently but over the years is in play on some level. Living within your means should be the first step on your journey to financial freedom. Expert Advice On Improving Your Home All Projects. Instant messaging has become so ubiquitous, an entire generation of internet users is probably unaware there was ever life without it. The MOA (Mode of Action) is just beginning to be understood. Re: 12-2, take the win right? by LWS » Thu Mar 21, 2024 2:49 pm. BENEFIT: * A patient who realizes a meaningful improvement in their A) transfusion frequency, B) transfusion …. Microsoft's popular Windows Live SkyDrive file storage service in the cloud is now available for iOS, allowing users to easily access files in their SkyDrive directly from their iD. by KTArsenal » Thu Feb 08, 2024 11:31 pm » in ImetelChat. These investment firms are willing to pay $3 when they could have literally paid $1’s last week …. Jacosa is correct in that thus far, Incyte's game plan has been to look for ways to extend a patient's response time to ruxolitinib. This will provide a forum for not only a transparent review of the data, but an opportunity to hear from, well, just about anyone. Find the latest Geron Corporation (GERN) stock quote, history, news and other vital information to help you with your stock trading and investing. chinese buffet in daytona beach florida The Udemy offering comes in the wake of the successful Duolingo IPO earlier this year. Geron has always had a strategy. by earfool » Thu Mar 14, 2024 9:09 pm. Comments made to the effect that Imetelstat is in a “different space” and the goal is to prolong life and improve the bone marrow picture. used tuff bilt tractor for sale Please note that the YouTube live video of the meeting will not broadcast until the. Speaker #3 was a patient from TX, who said she was ready to meet the Lord upon hearing her treatments were not working. I guess it's safe to say around 100 million shares will trade Friday. Unanswered topics; Active topics; Search; The team; FAQ; Login; Register; www. The carmaker is targeting corporate clients, parents with young children, and tourists as part of its ride-hailing service in Rwanda. My name is Sharon Sams Chandler and I am a 59 year old woman who lives …. Be nice to have some clarification here. Imetelstat is a first-in class telomerase inhibitor for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). php?f=1&t=690#p1818 FDA Thoughts on Accelerated Approval Wed Jul 18, 2018 7:34 pm. Just today, Nov 13, 2023, the European Medicines Agency approved a modification to the Imetelstat Paediatric Investigation Plan to allow imetelstat to be administered to children between the ages of 28 days and 18 years with MDS, JMML, …. Groundhog Day 2024: Punxsutawney Phil did not see shadow. The NDA submission is based on results from IMerge Phase 3, in which the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. Re: Executive Incentives (NDA Submission & FDA Approval) by Hoosier Investor » Mon Feb 13, 2023 1:06 am. These investment firms are willing to pay $3 when they could have literally paid $1’s last week in the open. The CE Shop specializes in online real estate education. The FDA notes that the p-value of HI-E, according to the 2006 guidelines, is p=0. The Geron staff (and data) will remind/clarify the meaningful benefits observed within the …. Inside the pouch is a metal disk that crystallizes the liquid causing it to heat up. The news of J&J terminating its collaboration in Sept 2018 was undoubtedly disheartening. In particular, in a partnership business, all partners share liabilities and profits equally, while in others, partners may have limited liability. After posting the JNJ-74856665 CT patient profiles of Ben Bennett (LinkedIn) and Eliana Keeling (Daily Mail UK), it really baffles me why Geron IR hasn't done the same???. bp & Kmall & others--- It appears that we all agree that Imetelstat has 'crossed all of the medical hurdles and tests' to transition from the EPA (in place) to the NDA approved. The Impress study top line data release has been extended by a little over a year to Feb 2025. rnb chord progression Kmall -- This exposure highlights the interest in fighting cancer (remember the Cancer Moonshot). I agree that sdrawkcabeman spoke eloquently and had imetelstat information that the common man should not. Cushing's Syndrome (Hypercortisolism) is a rare hormonal disorder caused by over exposure to the hormone, Cortisol. The AML study was extended by a year a while back. Share your opinion and gain insight from other stock traders and investors. voodoo curse removal Only a subset of people benefitted. “biopearl, I saw your latest post on Imetalchat regarding EMA and MF approval. Nice piece of info and I align with the call. I’ll call back the mentions in each of the previous two quarterly calls that Dr. This is a follow-up with additional thoughts. It is my hope that the flow of accurate, timely and honest information will give patients that are still alive and can benefit from Imetelstat, the hope, and treatment, …. Volume overload (many patients with MPD. As we approach the NDA acceptance date, if you are feeling a little anxious, ask your self the following: 1. Geron Announces Publication in The Lancet of Results from the IMerge Phase 3 Clinical Trial Evaluating Imetelstat in Lower Risk MDS • Business. We can now move beyond single-agent blood cancers and develop, in combinations with collaborators and partners, treatments (and …. Are you aware of any agent in development or in the clinic that has shown conclusive disease modification in this condition. by rccola335 » Wed Jan 17, 2024 3:52 pm. by biopearl123 » Thu Dec 28, 2023 7:19 pm. by biopearl123 » Wed Mar 13, 2024 1:54 am. Regarding the briefing documents, the law stipulates the FDA must release them …. Lane indicated positive results in his recent article. It’s a stretch and a guess but regarding the need for hospitalization to manage an adverse effect, that 1% sounds very favorable (if it’s …. Geron Corporation (GERN) shares are taking a pay cut of -39. ***As of now, this is the current list of "known" ex-Janssen and ex-JNJ employees now working at Geron. These two cases were discussed in detail in quarterly HEC meetings. InvestorPlace - Stock Market News, Stock Advice & Trading Tips By buying these best growth stocks of companies exploiting huge, ongoing trends InvestorPlace - Stock Market N. CKTC’s theory about why the FDA came out with guns blazing is interesting. Filed after the “to be made public deadline, but will be still considered by ODAC” was a filing from “ Institute for Clinical and Economic Review”. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML. sharing some of the things on twitter about imetelstat from the ASH meeting. However, I have little doubt that while we wait for marketing authorization, and perhaps even as Revenue begins, our ‘wait’ as investors will involve days and weeks of “max pain”. The remainder of their pipeline is in phase 1 or 2 but each candidate appears compelling and adds value. I may be naive but I view the upcoming ADCOM meeting as a positive (the market doesn't seem to). As both Bp and Ryan have pointed out in previous threads, highly unlikely that we see a late breaking abstract connected to recent findings in Australia with Drs Lane and Bruedigamnever say never, but I wouldn't be …. This entity plans to compare metadata from the Luspatercept studies with IMerge with plans for this evaluation to. Assistant United States Attorney. It's very slow moving in case you haven't noticed. HI, nothing new I have seen from the patient forum area. Nov 3, 2022 · Speaking of Anil Kapur, I think he quickly put to rest any concerns over Imetelstat vs. Jan 4, 2023 · If approved, imetelstat will enter an evolving MDS market, with its main rival considered to be Bristol-Myers Squibb's erythroid maturation agent Reblozyl (luspatercept), which was approved to. ET (Fireside Chat) 6th Annual Evercore ISI HealthCONx Conference. His "article" (blog) is nothing but more gaseous click bait. Imetelstat should be in great demand as a proven blood cancer medicine that is needed now (patients, investors, KOLs, potential partners) across the …. 5 years of hard lab work, no vacations and the reward of a discovery of a new pathway!. made an individual purchase of 170,940 shares of the …. by Ryan » Mon Feb 26, 2024 10:44 pm. You can take this medically-reviewed depression quiz to help determine whether you have symptoms of depression and if you should speak with a mental health professional. Greg Titone - Regional Business Director Gulf Coast, Geron Corporation. Forum rules - Comments must be civil and on topic - Back up claims with evidence/reasoning/sources (posting links is allowed) - No commercials/harassment/spam. info Board index ImetelChat; Search; More stuff. made an individual purchase of 170,940 shares of the Company’s common stock. 1/ Ferroptosis (Inflammation in a variety of diseases) 2/ Telomerase & Telomeres. As far as I can tell from John Scarlett's comments, everything is on track and ready to go. Feb 12, 2024 · Re: Everyone catch this one last night? by LWS » Mon Feb 12, 2024 4:12 pm. Speaker #4 is Dr / expert from Cornell, non-sponsored who had consulted with Geron in the past "Enthusiastic to have Imetelstat as a treatment option. 0835 ET - Geron says the FDA didn't grant is request for a priority review of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes and instead assigned a standard review and target action date of June 16, 2024. Re: More JnJ Trouble on The Horizon? by LWS » Thu Apr 04, 2024 4:02 pm. ), living longer, minimal side effects, combinations. 24 million+ (edited from 30 Million, I overestimated) shares traded here say it’s a spring, or a slinkie. IHG One Rewards is currently featuring a new promotion, allowing you to earn 1,000 United MileagePlus miles after completing a 2-night stay. Combos with Imetelstat will take this to a whole other level. Now they look spot on and sagacious. by LWS » Wed Feb 22, 2023 4:26 am. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fish Jr, Biopearl, kmall, and every member who has lent their voice to our community, your contributions have not gone unnoticed. CUSIP NO: 374163103 13G Page 3 of 5 Pages. 2024 should be quite the year for us. “ Just wanted to share with you that HI 's concerns and questions in Imetelchat are excellent. 1549 Topics 6760 Posts Last post Re: PPS by LWS View the latest post Sat Apr 20, 2024 4:03 pm Login • Register Username: Password: I forgot my password. OVERVIEW The full value proposition associated with the IMproveMF Phase 1 trial isn’t being properly recognized by the investment community. by jayfish101 » Sun Apr 14, 2024 12:41 am. RC either we are missing something or the FDA is. I think the after hours volume is more impressive than the price - tomorrow will be interesting. IMproveMF is a Phase 1 trial designed to identify a safe dosage regimen for the combination of Imetelstat + Ruxolitinib in a frontline MF setting. Certainly, JS knows more than he is telling us about partners and buyouts. by biopearl123 » Tue Feb 06, 2024 3:51 pm. target nearest to me The biggest negative is likely the $0. bp, Ryan --- The count is now 10 (ODAC Imetelstat meeting, March 14th) Most on this board follow the science, publications, conferences and medical successes of Imetelstat (earth 1), that judge Imetelstat to be a much needed and deeply researched blood cancer medicine. Probably looking at a five year timeline (at least) for development and moving through all phases of required study. If approved, imetelstat will enter an evolving MDS market, with its main rival considered to be Bristol-Myers Squibb's erythroid maturation agent Reblozyl (luspatercept), which was approved to. Once the Event Materials are posted, hopefully, today, the two PDF files everyone will want to look at are: • FDA Briefing Document. Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis • Business Wire • 12/06/2023 01:00:00 PM. There is always an infinitesimal chance of rejection, but it is not zero percent. That is now on the front-burner, with Geron's future and viability on the line. by Ryan » Tue Feb 27, 2024 4:42 am. Furthermore, it's in a separate phase 3 which should produce interim data in early 2024. More specifically; a combination of a telomerase inhibitor and a Bcl-2 inhibitor are useful in treating hematological cancers, including AML. Apr 4, 2024 · Re: More JnJ Trouble on The Horizon? by LWS » Thu Apr 04, 2024 4:02 pm. --(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 189,850 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. At the time of designation, myelodysplastic syndromes affected approximately 2 in 10,000 people in the European Union (EU). shared dispositive power 25,625,606 9. by LWS » Thu Mar 14, 2024 8:46 pm. In total there are 23 users online :: 0 registered, 0 hidden and 23 guests (based on users active over the past 5 minutes) Most users ever online was 379 on Thu Jul 29, 2021 4:50 am. I just wanted to highlight the great preparation, composure, and representation by Faye and team. What Didn't Happen Wed Mar 24, 2021 6:13 am Drug on the market by 2017 (yes that was once projected), current timeline for approval has lead to emergence of many. Prediction: Sometime between today (November 16) and the end of this year (2023) Geron's PPS will be over $4. between 4:40 and 5:30 more than 3. Filed after the "to be made public deadline, but will be still considered by ODAC" was a filing from " Institute for Clinical and Economic Review". The fact that the FDA has already allowed continued access to Imetelstat beyond the actual study was the basis for that comment. I would feel comfortable placing this estimate roughly in the middle at around $8 - $10 Billion. I’m seeing new underwriters in TD Cowen and Barclays. This preparation was clear, but it was also clear to me and assume. Interesting item I excerpted from a continuing education quiz for doctors that I received via Clinical Care Options and Amer Zeidan. I can see a well meaning journalist make an honest mistake. Probably should submit to Merriam-Webster for new word of the year. by biopearl123 » Fri Mar 01, 2024 6:21 am. Reblozyl as far as the data up to this point indicates, as well as Imetelstat's potential for commercial market share once approved. by Commsman » Tue Nov 14, 2023 2:52 am. Review Material: SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded. (RTTNews) - The Canadian market ended modestly higher on Wednesday, led by gains in energy and materials sectors. Good presentation with Imet highlights. by LWS » Fri Dec 22, 2023 4:39 pm. Yet, through your insightful discussions, shared experiences, and words of encouragement, you've shown that hope is not lost. by cheng_ho » Thu Feb 29, 2024 2:35 pm. I don't believe that there has ever been any deviation from that pattern. As a user you agree to any information you have entered to being stored in a database. ImetelChat message board Home Pre-clinical Clinical Commercial Events Contact Pre-clinical research There exists a history of preclinical research on telomerase and imetelstat, ignited after the discovery of telomerase by Carol Greider and Elisabeth Blackburn in 1984. by Hoosier Investor » Fri Dec 22, 2023 3:13 am. Re: Hundreds of views every day. by biopearl123 » Fri Mar 15, 2024 3:28 pm. solid cancers and combinations). The discussion has come down to the scheduling of the Oncology ADCOM meeting featuring Imetelstat and John Scarlett's views on the business going forward ("Imetelstat is bigger than all of us"). shared voting power 24,443,571 7. It basically means they get down to business. xenia shooting today by Ryan » Thu Apr 11, 2024 6:17 am. The real challenge for Geron with the FDA has been going on behind closed doors, and that's the wording of imetelstat's labeling. by biopearl123 » Fri Apr 12, 2024 1:06 am » in ImetelChat. Scarlett and Geron announced 3 new Clinical Programs (IMproveMF, IMpress, and TELOMERE) and one new Pre-Clinical Program to "explore the use of Imetelstat as a single agent and in combination with current standard of care treatments to expand the potential application of Imetelstat. Jeffrey Savidge mentioned this in his comments to the FDA review: "an ex-marine who courageously put his life on the line fighting for his country in Vietnam and Cambodia. Iron studies, platelets, and white blood cell counts have been within. How retirement investors can assess the costs of their funds and benefit by choosing the lowest-cost options. Partnerships: A formal arrangement by two or more parties to manage and operate a business and share its profits. Bridge, thanks for trying to contact me re new Geron patent filing. in False Claims Act investigations. , December 21, 2023--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 417,490 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. We are all waiting for the formal approval of Imetelstat. Nov 24, 2022 · Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation Barcelona, Spain Aug 2020 - Present 2 yrs 4 mos. 5 million, while general and administrative. January 19, 2021 - Imetelstat exhibited dose-dependent inhibition of the telomerase target, as evaluated by reductions in telomerase activity, human reverse transcriptase levels, and telomere. And have read the words of some awesome writers. The first patient (1/45) was dosed in June and the trial was ~50% enrolled a couple months ago, and the recent Dr. info Board index ImetelChat; Search; Dr. The likely scenario is that Geron provided the numbers for the 2006 and 2018 guidelines and then made the case for why the 2018 numbers should be used. Imetelstat---It all seems to be tied together in one important cancer treatment package, that may lead to cancer cures (TBD by many years of research) --- transfusion independence, disease modification, telomerase, telomeres, ferroptosis, feeling better (fatigue, quality of life, etc. In combinations (research for many years to. (CMG) announced a profit for its fourth quarter that increased from last year but missed the Street estim (RTTNews) - Chipotle Mexican G. So far only a few comments posted. There are many fans who read the Geron Imetelchat board which was started by a patient with MF who could not avail himself of Imetelstat treatment and subsequently died. More important will be the Vote question. Like Patient #3, he was initially treated with Placebo (2 rounds. NO ONE can find an ODAC (Oncology Data Advisory Committee) positive recommendation (March 14th) that has ever been rejected by the FDA. As a matter of fact, I believe he said that Imetelstat has the potential to treat up to 3x as many patients. The name and details of the European partner have the potential to move the price significantly - I think the FDA and European approvals are. watching the webcast today I feel even more strongly that they are trying to hold off as long as possible on a european partner - I feel they are hoping to sell without the complication of having a european partner - the interim analysis for MF will be the first half of 2025 as will the. Fellow Board Members: by biopearl123 » Fri Jun 17, 2022 7:07 pm. Luspatercept, does that mean that Imetelstat …. This is my way of chatting with summaries, updates, new findings and what I believe to be conclusive evidence of Imetelstat's value in a variety of blood cancers now (single-agent) and in various combinations going forward. , June 29, 2023--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access …. Note: One of the most important features of Imetelstat is the very positive "fatigue-factor" --- that is this medicine can make you feel better and improve the quality of life (enjoy life). 18 million in consulting fees to more than two-thirds of the doctors. By clicking "TRY IT", I agree to receive newsletters and promotions fr. Ryan, you are always teaching me new words. Not too much time left in 2023 for JS to make good on two promises. The way you start your morning can make or break the rest of your day. how much is a 1915 coca cola bottle worth Or, the thing about good studies. A first-in-class investigational drug with the potential to extend and enhance lives. THRSF: Get the latest Thunderbird Resorts stock price and detailed information including THRSF news, historical charts and realtime prices. At the moment, there seems to be an effort to keep the price under $2. MAIA (THIO) and Geron (Imetelstat) are covering most of the telomerase cancer ongoing opportunities from liqiud to solid. I have received a response from Aron Feingold of Geron. Geron ( NASDAQ: GERN) is a Nasdaq-listed biotech that has been around a long time - its IPO took place in 1996 at $8 per share, although the company has never won approval for or commercialized a. Advertisement These heat pads are. Geron Corporation (NASDAQ: GERN) is diligently progressing towards the regulatory milestones for Imetelstat, its potential therapeutic for hematologic myeloid malignancies, particularly targeting myelodysplastic syndromes (MDS). Will be interesting to see what their analysis reveals. by LWS » Wed Jan 31, 2024 7:15 pm. Claudia B are independently interacting with journalists, who find their discoveries news worthy.