ImetelChat

12 to 2 We made it over the finish line. There are many other considerations now. The (MOA) will be the subject of many research publications going forward. The FDA accepts almost all ODAC recommendations. Imetelstat's strength, as an important blood cancer medicine, will be in combinations. The sa...

Webcast Information ==================== 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....

CDER & ODAC (parts of the FDA) are working together. Imetelstat is a top 10 new medicine for 2024 ================= CDER plans to provide a free of charge, live webcast of the upcoming advisory committee meeting (ODAC, March 14). If there are instances where the webcast transmission is not successf...

Common sense should prevail favoring the newer 2018 guidelines. ODAC and the FDA are composed of some very smart people.

Let's not forget the unique mechanism of action (MOA) based upon two methods to kill cancer stem cells ( 1/ Ferroptosis, 2/ Telomerase & Telomeres) that is just beginning to be recognized and understood as an important part in the treating of blood cancers and beyond. Imetelstat may not be the "perf...

Posted by FDA (Feb. 26, 2024) There were no Hy’s Law cases. Two patients had both post baseline elevated bilirubin > 2 x ULN and ALT≥ 3 x ULN, i.e. potential Hy’s Law cases. These two cases were discussed in detail in quarterly HEC meetings. Hy’s Law criteria were not met because both patients had ...

What are the medical negatives? Imetelstat will be approved (IMO). Let's hear what the KOLs have to say about Imetelstat's medical successes. ===================== Previous: The benefits clearly are important and significant. The risks are manageable and reversible. The Positives: 1/Transfusion ind...

Too many opinions now. Some are based upon science and medical trials. Others are based upon hearsay and fabrications. ODAC, we believe, will be fair and will not be swayed by special interests. The ball is certainly in their court, with little time on the clock. Tempers are becoming a bit too heat...

There really is no more to say until ODAC and the KOLs speak on Thursday. All recommendations (good, bad or indifferent) will come from ODAC on March 14th concerning Imetelstat. Everything that I have viewed is in the good (or better) category. This is a powerful, unique blood cancer medicine. The s...

7 Days --The Oncology ADCOM meeting is one week from now (Imetelstat ODAC meeting--- March 14, 2024) I believe that World 1 (Medical Successes & Scientific Breakthroughs for Imetelstat) will finally prevail, as the KOLs (in a public hearing) testify about patients' immediate needs, safety and uniqu...

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. However, most people (earth 2...

The last hurdle before the finish line for Imetelstat The ODAC meeting (March 14) and the full FDA (June 16) are in focus now. Much of the discussion on this board has been about the FDA and its supposed shortcomings. The positive features of Imetelstat appear to be overwhelmingly positive, and the...

Imetelstat works (safe and effective) and is proven for blood cancers in a variety of ways (note KOLs and ODAC meeting March 14th). Pfizer's acquisition ($43B) will increase the interest in and value of Imetelstat. The potential in combinations and chemotherapy is vast for many cancers, both blood ...

Some comments from Feb. 28 to ponder. March 14 (ODAC meeting) is the next critical date. ====================================  Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results February 28, 2024 June 16, 2024 PDUFA date for imetelstat NDA for the t...

Press Release Details Geron to Announce Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced that it will release its fourth quarter and full-year ...

Since the list of negatives has not been added to, I am assuming that there is nothing important or credible to be added. We will hear something on Feb. 28, with the ODAC meeting (March 14) highly anticipated. We would like to know more about that meeting's structure and the KOLs (and others) that ...

bp --- Later today, I will go back and modify the post that contains "comments regarding blood shed by violence ", as you suggest. As far as Imetelstat goes, so goes ODAC and the KOLs that they will bring into this discussion. March 14th is only 3 weeks away, and I believe there will be some commen...

Kmall -- The subject here is blood (blood cancers, horseshoe crab blood, blood of our allies). All are important. The FDA is also of great importance and needs to be allowed to operate based upon the successful trials and patients' needs. We are talking about humanity, and a functional FDA in a dem...