Search found 1665 matches
- Fri Mar 15, 2024 2:49 pm
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 2698
Re: Quite Surprising that....
Who was the second no vote?
- Fri Mar 15, 2024 5:56 am
- Forum: ImetelChat
- Topic: A note from your board moderator
- Replies: 3
- Views: 971
A note from your board moderator
Just got home after important family obligation. Obviously a lot has happened but was able to intermittently tune in. Geron hit it out of the park. Great presentations all around. Masterful, informed, confident. I was struck by a couple of things besides what has been discussed here today. Did I und...
- Wed Mar 13, 2024 11:39 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1842
Re: CKTC
KT, well tomorrow is a seminal event for sure. My thanks to everyone who has contributed to furthering our understanding of this drug and the studies that support it (or don’t), guess its who you ask…:)
- Wed Mar 13, 2024 7:57 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1842
Re: CKTC
Well, if the 2018 guidelines are used the results look stellar and include a strong endorsement for HI. If this end point is excluded by using earlier, older guidelines we still have 1. Primary endpoint reached. 2. Key secondary endpoint reached. 3. Caveats re cytopenias etc. Points 1 and 2 are fact...
- Wed Mar 13, 2024 4:41 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1842
Re: CKTC
Yup, I think you have hit on an important point. The first patient was enrolled in 2015 in part 1, obviously before the 2018 criterion were adopted. Will the FDA require the 2006 criterion to obtain because of that? We are talking about a study start to top line (not yet even at final completion dat...
- Wed Mar 13, 2024 3:40 pm
- Forum: ImetelChat
- Topic: CKTC
- Replies: 8
- Views: 1842
CKTC
First off, your posts have been incredible and really helped to make sense of a what amounts to a very surprising FDA position paper. I can understand that the FDA would want to look at the negatives carefully. In this case however using criterion for HI that are almost 20 year old and are no longer...
- Wed Mar 13, 2024 3:30 am
- Forum: ImetelChat
- Topic: Basic Considerations....
- Replies: 13
- Views: 2529
Re: Basic Considerations....
Right you are. Geron is going to have to tread carefully not to irritate the FDA which as you point out used IWG criterion that are almost 20 years old and have been updated at least twice since then. Also the astounding HI rates in the placebo group, well, I tried to find confirmation. Just not sur...
- Wed Mar 13, 2024 1:54 am
- Forum: ImetelChat
- Topic: Dr. Michael Savona
- Replies: 0
- Views: 884
Dr. Michael Savona
Presenting for Geron at FDA Thursday. Impressive.
- Wed Mar 13, 2024 12:20 am
- Forum: ImetelChat
- Topic: Risk vs. Benefit
- Replies: 6
- Views: 1662
Re: Risk vs. Benefit
KT pretty strong line up on the Geron side:
https://www.fda.gov/media/176961/download
As to Dr. Hunter, pretty sure he is well aware of the limitations of present day treatments.
https://www.fda.gov/media/176961/download
As to Dr. Hunter, pretty sure he is well aware of the limitations of present day treatments.
- Tue Mar 12, 2024 11:47 pm
- Forum: ImetelChat
- Topic: Risk vs. Benefit
- Replies: 6
- Views: 1662
Re: Risk vs. Benefit
KT, yes the panel will look at everyone in the study including non responders. Right now I am looking at this as the FDA is evaluating a study that they approved and evaluated on a rolling schedule. The study met its primary end point with a strong P value. The study met a key secondary end point wi...
- Tue Mar 12, 2024 9:26 pm
- Forum: ImetelChat
- Topic: Geron Responds…
- Replies: 5
- Views: 1461
- Tue Mar 12, 2024 8:53 pm
- Forum: ImetelChat
- Topic: Geron Responds…
- Replies: 5
- Views: 1461
- Tue Mar 12, 2024 8:12 pm
- Forum: ImetelChat
- Topic: Risk vs. Benefit
- Replies: 6
- Views: 1662
Re: Risk vs. Benefit
I have to agree. Hematologic improvement (a reduction of 4 units every eight weeks) still amounts to a lot of transfusions saved. Having a very high bar to assess actual benefit makes the choices clear. A personal anecdote: When I started catheter based treatment for A-fib almost 20 years ago, the b...
- Tue Mar 12, 2024 7:44 pm
- Forum: ImetelChat
- Topic: Hy’s law
- Replies: 8
- Views: 1220
Re: Hy’s law
I was blessed to have Hy Zimmerman as a GI professor when I was in med school. A key component to Hy’s law is “ No other reason can be found to explain the combination of increased aminotransferase and serum total bilirubin, such as viral hepatitis, alcohol abuse, ischemia, preexisting liver disease...
- Tue Mar 12, 2024 4:22 pm
- Forum: ImetelChat
- Topic: ADCO comments
- Replies: 5
- Views: 1111
Re: ADCO comments
Still reading and digesting. Might go back and buy the article recently published in Cell re disease modification. There is a lot in the FDA postings. Glad oncology experts will be able to debate the pro’s and con’s. CKTC’s point about the final question is central. I think it can be boiled down to ...
- Tue Mar 12, 2024 3:59 pm
- Forum: ImetelChat
- Topic: ADCO comments
- Replies: 5
- Views: 1111
Re: ADCO comments
Mistergern, you are right, I don’t really don’t know what the FDA will do. I was viewing this as an up or down vote. I just wanted to be sure Bridge had the opportunity to clarify his comments. My comments were based only on not seeing any statement in the FDA material that an additional study was w...
- Tue Mar 12, 2024 3:13 pm
- Forum: ImetelChat
- Topic: What's the motivation here?
- Replies: 13
- Views: 1545
Re: What's the motivation here?
Bridge, thank you for taking the time to clarify the context of your comment. Taken in context, now that the notes are actually out we don’t have to be concerned about the likelihood of the necessity of the FDA requiring an additional trial.
- Tue Mar 12, 2024 5:57 am
- Forum: ImetelChat
- Topic: Additional comments to FDA
- Replies: 10
- Views: 2622
Re: Additional comments to FDA
Big fun, nice to see you posting thanks for your thoughts. First off we are in the big time now, everyone on that panel has a reputation and a level of expertise that allows the FDA to know they are getting very high quality input. Dr. Hunter is on the board by invitation, you can be sure he didnt’ ...
- Mon Mar 11, 2024 11:27 pm
- Forum: ImetelChat
- Topic: What's the motivation here?
- Replies: 13
- Views: 1545
Re: What's the motivation here?
I have not seen any supplemental materials posted regarding the ODAC as yet. If Bridge has seen them or knows where they are posted, it would be helpful for us to review them. I highly doubt an additional study would be recommended before the ADCOM has a chance to review and discuss. It’s pretty obv...
- Mon Mar 11, 2024 9:37 pm
- Forum: ImetelChat
- Topic: Finally, disease modification?
- Replies: 4
- Views: 852
Re: Finally, disease modification?
Ryan, I did not pay for access. Why pay for what we already know? The last line of the summary basically says it all but I can not copy it due to restrictions. Should have the FDA supplementary materials soon.