Search found 581 matches

by LWS
Wed Mar 27, 2024 3:33 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6830

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...
by LWS
Wed Mar 27, 2024 12:08 am
Forum: ImetelChat
Topic: Down the road, way down the road
Replies: 5
Views: 1155

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...
by LWS
Tue Mar 26, 2024 9:41 pm
Forum: ImetelChat
Topic: Down the road, way down the road
Replies: 5
Views: 1155

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...
by LWS
Tue Mar 26, 2024 4:03 pm
Forum: ImetelChat
Topic: Down the road, way down the road
Replies: 5
Views: 1155

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...
by LWS
Sat Mar 23, 2024 11:29 pm
Forum: ImetelChat
Topic: Sergei Left a comment on LinkedIn
Replies: 2
Views: 1118

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 ...
by LWS
Fri Mar 22, 2024 6:06 pm
Forum: ImetelChat
Topic: Sergei Left a comment on LinkedIn
Replies: 2
Views: 1118

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...
by LWS
Fri Mar 22, 2024 2:26 pm
Forum: ImetelChat
Topic: Ferroptosis Article (NIH)
Replies: 4
Views: 780

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/ ...
by LWS
Thu Mar 21, 2024 2:49 pm
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 5
Views: 1350

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...
by LWS
Wed Mar 20, 2024 5:39 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6830

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...
by LWS
Tue Mar 19, 2024 6:36 pm
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133411

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 ...
by LWS
Tue Mar 19, 2024 2:52 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6830

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).
by LWS
Mon Mar 18, 2024 7:52 pm
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 5
Views: 1350

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....
by LWS
Mon Mar 18, 2024 6:20 pm
Forum: ImetelChat
Topic: PPS
Replies: 79
Views: 133411

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...
by LWS
Sun Mar 17, 2024 9:53 pm
Forum: ImetelChat
Topic: Quite Surprising that....
Replies: 10
Views: 2698

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...
by LWS
Sun Mar 17, 2024 5:43 pm
Forum: ImetelChat
Topic: Vote 12-2 in Favor
Replies: 9
Views: 1930

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...
by LWS
Sat Mar 16, 2024 10:36 pm
Forum: ImetelChat
Topic: There are many ways to think about partnering
Replies: 177
Views: 366650

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...
by LWS
Sat Mar 16, 2024 5:58 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6830

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...
by LWS
Fri Mar 15, 2024 4:50 pm
Forum: ImetelChat
Topic: Quite Surprising that....
Replies: 10
Views: 2698

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 ...
by LWS
Thu Mar 14, 2024 8:46 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5438

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...
by LWS
Thu Mar 14, 2024 2:13 am
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5438

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....