ImetelChat

Kmall --- I totally agree with you. I thought about this for a longtime, and decided that we have such problems, because the 'good-guys' tend to be very quiet. Everything worthwhile for humanity is on the line. After-the -fact is too late.

This is another off-subject post. I doubt if anyone on this board would disagree with the fright, bewilderment and the challenge to the USA. "United we stand, divided we fall". Blood is important to all species. This board is especially interested in human blood transfusions, at this point in time....

Thank you bp for the reference These limited criticisms of Imetelstat are characterized as a "soft endorsement". I suspect that the KOLs (March 14th ODAC meeting) will have some "strong endorsements". These are early days in the life and uses of Imetelstat. Some prefer to wait and see (very conserv...

Negatives???? I do not have access to the Mayo editorial. With any new and transitional medicine (Imetelstat) not everything can be known in the early stages. Some features will be uncovered (like 2 ways to kill cancer cells) that were not known earlier (some positive and, perhaps, some negative). ...

The Medical Negatives for Imetelstat Continued The Positives: 1/Transfusion independence 2/ Overall Survival Time 3/ Disease modification 4/ Two ways to kill cancer cells (MOA) -- normal cells OK 5/ Off label uses (in combination --- chemotherapy and other promising combinations when approved) 6/ V...

I signed the petition. Kmall -- In both cases, the FDA is in focus. We all agree that the FDA delays are unwarranted and unnecessary (both horseshoe crabs & blood cancers). I believe that the KOLs will be overwhelmingly positive (March 14th) supporting Imetelstat, and the FDA will follow ODAC's rec...

The FDA in Focus Kmall - The "correlation" with the FDA, one way or the other, has been discussed on this board for a long time. There has been much speculation about why Imetelstat has been "derailed" and not granted "priority review". Some have suggested "shenanigans", while others have suggested...

The PPS for Geron is a Mystery As far as I can tell, from what I read, Imetelstat is medically proven to be a very good medicine for a variety of blood cancer conditions (alone, combinations, ongoing trials, etc.). Apparently, many large institutions are accumulating Geron's stock. There are no "sh...

Call for Medical Negatives Concerning Imetelstat This thread was created to list medical negatives that would reduce the chances of ODAC's positive recommendations (from March 14th Imetelstat meeting). The conclusion that I have come to is that the list has no items because none exist. There have b...

PPS to be Determined by ODAC (March 14th Meeting) Recommendation to FDA There is little doubt now (none, as far as I am concerned) that the NDA for Imetelstat will be granted. My $4 PPS prediction by Valentines Day was premature. Goldman Sachs still has a "Buy" on Geron with a $4 price target. The ...

ODAC Composition We know that ODAC (Oncology Data Advisory Committee to the FDA) will meet on March 14th, 2024 and the subject will be Imetelstat. This is their first meeting since Nov. 16, 2023. John Scarlett suggested that the current ODAC group is more flexible than prior groups (fireside chat)....

Kmall -- This exposure highlights the interest in fighting cancer (remember the Cancer Moonshot). Imetelstat should be in great demand as a proven blood cancer medicine that is needed now (patients, investors, KOLs, potential partners) across the board. The game was one of the best ever. ==========...

The FDA (CDER & ODAC) both are very familiar with Imetelstat (successes & potential). With the EAP in place, and no significant medical negatives, there is nothing (that I am aware of) that would prevent NDA (Imetelstat) approval. Together CDER and ODAC are bringing us the March 14th webcast. CDER ...

Rccola --- Thank you for this post. The "Brief Summary" shows some very important initial steps in treating AML, MDS and JMML. This is the first clinical trial, that I am aware of, that combines Imetelstat with "chemotherapy drugs". It calls to attention the importance of Imetelstat in combinations...

I cannot think in terms of the "FDA v. Geron" . The FDA (ODAC) and Geron are on the same side when it comes to patients' needs and patients' safety. Imetelstat is unique. It excels in overall survival time, disease modification, safety profile, transfusion independence, and maintaining the quality ...

Ryan -- I do not know anything beyond what has already been posted. As far as I can tell, March 14th and everything leading up to that date will be very public and transparent. This meeting appears to be a joint effort between ODAC and CDER (both parts of the FDA). =================================...

Ryan --- As you and Geron summarize, the list of Imetelstat accomplishments and achievements to date (with huge potentials going forward -- combinations, oral form, new formulations) appears to be overwhelmingly positive. ODAC will look for medical negatives, but, as far as I can tell, there are no...

Off-Label Uses Once Imetelstat is Approved I would ask you to expand your view point beyond approval in june (really hope this is the case) basically pps focus for June date could be not quite the best focus. --- from Zhears As I understand it, once Imetelstat gets approved (depending on ODAC recom...