Search found 581 matches
- Wed Mar 27, 2024 3:33 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 31
- Views: 6869
Re: FDA v. Geron
It very unlikely that the FDA would reject their ODAC's recommendation for approving Imetelstat. Still we are a bit nervous about the FDAs "devil's advocates" comments (March 14) and the (NO) vote of the chairperson. The FDA has much on its table these days, as their past and future is now being re...
- Wed Mar 27, 2024 12:08 am
- Forum: ImetelChat
- Topic: Down the road, way down the road
- Replies: 5
- Views: 1190
Re: Down the road, way down the road
I will refer to him as Dr. Smith. To me, the subject of interest is the "litigation economics" and the fact that Sergei (Dr. Sergei Gryaznov, now at MAIA)) spent so much time with both companies developing Imetelstat and THIO as important cancer medicines. Which patents, with his name belong to Ger...
- Tue Mar 26, 2024 9:41 pm
- Forum: ImetelChat
- Topic: Down the road, way down the road
- Replies: 5
- Views: 1190
Re: Down the road, way down the road
jay --- Most men that I know with PhDs, that do not have medical degrees, prefer to be called (Mr.) . The interesting thing about Mr. Smith, is that his background is litigation economics. Assuming that the FDA does not create some last-minute difficulty with the NDA approval and takes ODAC's posit...
- Tue Mar 26, 2024 4:03 pm
- Forum: ImetelChat
- Topic: Down the road, way down the road
- Replies: 5
- Views: 1190
Re: Down the road, way down the road
News about Dr. Stan Smith (Will patent considerations bring Geron and MAIA together in some form of collaboration?) ============ MAIA Biotechnology Announces Share Purchase by Director Stan Smith, PhD in a $2.9 Million Private Placement March 22, 2024 3:00 PM EDT Tweet Share E-mail Dr. Smith has pa...
- Sat Mar 23, 2024 11:29 pm
- Forum: ImetelChat
- Topic: Sergei Left a comment on LinkedIn
- Replies: 2
- Views: 1124
Re: Sergei Left a comment on LinkedIn
Some History for those that are new to this board ======================== Posted Dec. 27, 2023 Telomerase Inhibitors for Potentially 90% of all Cancers MD Anderson and the University of Texas medical unit are already partners. They are building the ulitmate cancer research and treatment center in ...
- Fri Mar 22, 2024 6:06 pm
- Forum: ImetelChat
- Topic: Sergei Left a comment on LinkedIn
- Replies: 2
- Views: 1124
Re: Sergei Left a comment on LinkedIn
I am sure Sergei is very happy. MAIA is getting a very strong tail-wind from Imetelstat's very positive ODAC recommendation. Some have previously suggested that there are overlapping patents. It would make both good business sense and good medical sense for both companies (Geron and MAIA) to find a...
- Fri Mar 22, 2024 2:26 pm
- Forum: ImetelChat
- Topic: Ferroptosis Article (NIH)
- Replies: 4
- Views: 787
Re: Ferroptosis Article (NIH)
Previous from Sat Dec 30, 2023 Imetelstat for Diseases other than Cancer With the discussion of Ferroptosis comes the discussion of Imetelstat for diseases other than cancer. This will be of interest to potential partners and collaborators. 1/ Ferroptosis (Inflammation in a variety of diseases) 2/ ...
- Thu Mar 21, 2024 2:49 pm
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 5
- Views: 1467
Re: 12-2, take the win right?
Everyone agreed (including the 2 NO ODAC votes) that Transfusion Independence was important. Imetelstat is not the "perfect" blood cancer medicine, but it is "very good" in many situations and is needed now by patients and it is unique. In combinations (research for many years to come) with importan...
- Wed Mar 20, 2024 5:39 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 31
- Views: 6869
Re: FDA v. Geron
Imetelstat is an inch from being an approved medicine by the FDA and others. NO ONE can find an ODAC (Oncology Data Advisory Committee) positive recommendation (March 14th) that has ever been rejected by the FDA. Then off-label uses can be explored including new combinations. Somewhere over the rain...
- Tue Mar 19, 2024 6:36 pm
- Forum: ImetelChat
- Topic: PPS
- Replies: 79
- Views: 133483
Re: PPS
Geron raises $150M as the PPS passes $3.25 after ODAC positive recommendation. ============== Geron Corporation Announces Pricing of $150 Million Underwritten Offering of Common Stock and Pre-Funded Warrants March 19, 2024 FOSTER CITY, Calif.--(BUSINESS WIRE) -- Geron Corporation (Nasdaq: GERN), a ...
- Tue Mar 19, 2024 2:52 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 31
- Views: 6869
Re: FDA v. Geron
A question for the board:
Has an ODAC (oncology advisory) positive recommendation ever been rejected by the FDA? I cannot find one.
If yes, can you share the case? The 'black-box' issue, while interesting, is not all that important (IMO).
Has an ODAC (oncology advisory) positive recommendation ever been rejected by the FDA? I cannot find one.
If yes, can you share the case? The 'black-box' issue, while interesting, is not all that important (IMO).
- Mon Mar 18, 2024 7:52 pm
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 5
- Views: 1467
Re: 12-2, take the win right?
My thoughts --- Perhaps the FDA's role, at this point in the process, is to act as 'devil's advocate' coming out at the gate and starting out with as many negatives as they have heard about. It seems to me that they cannot know everything, in proper perspective, about every new unapproved medicine....
- Mon Mar 18, 2024 6:20 pm
- Forum: ImetelChat
- Topic: PPS
- Replies: 79
- Views: 133483
Re: PPS
Even with the good news from ODAC, Geron's PPS is still under pressure. Some is profit taking. Other factors involve the computer algorithm, that appears to still be in control. I don't believe the importance of this transfusion independence decision (along with quality of life & survival time) is a...
- Sun Mar 17, 2024 9:53 pm
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 2702
Re: Quite Surprising that....
Bigfun --- The researchers have been looking for biomarkers to separate those patients that can benefit from Imetelstat from those that cannot. So far, none have been found. I believe that is one of the reasons why the Chair voted no. Most (12) believed that it was important to have this medicine i...
- Sun Mar 17, 2024 5:43 pm
- Forum: ImetelChat
- Topic: Vote 12-2 in Favor
- Replies: 9
- Views: 1933
Re: Vote 12-2 in Favor
Can anyone find a FDA rejection that happened after an ODAC recommendation? The favorable vote from ODAC (cancers) for recommending Imetelstat contained 2 NOs (one surprisingly from the Chairperson). 97% of ADCOM (all medicines) recommendations are accepted by the FDA. However, no one can find an e...
- Sat Mar 16, 2024 10:36 pm
- Forum: ImetelChat
- Topic: There are many ways to think about partnering
- Replies: 177
- Views: 366803
Re: There are many ways to think about partnering
Now that one hurdle has been passed successfully (Transfusion Independence), there is a bright future ahead for Imetelstat, with many possibilities. Geron has never been in a better negotiation position. It is time to think about deep pocketed partners. In the USA, JNJ and AbbVie have been very inv...
- Sat Mar 16, 2024 5:58 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 31
- Views: 6869
Re: FDA v. Geron
I was surprised how aggressively the FDA came out of the starting gates (devil's advocate ?). In the morning (March 14th), it appeared that Imetelstat was on the ropes. However, by the afternoon it all turned around and the medicine was approved by a 12 to 2 vote by ODAC. The subject at hand was tra...
- Fri Mar 15, 2024 4:50 pm
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 2702
Re: Quite Surprising that....
These were the no votes (12 yes, 2 no) 2. AC-Ravi Madan(Chair) NO 8. AC-Mark Conaway NO As I remember some of the no reasons were: 1. Only a subset of people benefitted 2. Unnecessary disease in those that did not benefit 3. No biomarkers 4. Quality of life (feeling better) is too subjective to be ...
- Thu Mar 14, 2024 8:46 pm
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5444
Re: March 14th
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...
- Thu Mar 14, 2024 2:13 am
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5444
Re: March 14th
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....