Search found 1670 matches
- Sat Mar 16, 2024 6:27 pm
- Forum: ImetelChat
- Topic: Public Hearing Comments (Patient #3; Patient #9)
- Replies: 4
- Views: 1291
Re: Public Hearing Comments (Patient #3; Patient #9)
HI, thanks for posting this link. I am planning to spend a lot of tomorrow reviewing the parts I missed. bp
- Sat Mar 16, 2024 3:05 pm
- Forum: ImetelChat
- Topic: 4 years of TI
- Replies: 1
- Views: 996
Re: 4 years of TI
I wonder if the two FDA “no” votes realize what a miracle that is.
- Sat Mar 16, 2024 6:46 am
- Forum: ImetelChat
- Topic: The fight to white out the black box
- Replies: 0
- Views: 1293
The fight to white out the black box
CKTC’s theory about why the FDA came out with guns blazing is interesting. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. We hate being directed by others who have never even seen a patient...
- Fri Mar 15, 2024 11:43 pm
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 3350
Re: Quite Surprising that....
Great point, the FDA sets a statistical bar, it is met, but once it is, it’s still not enough? Thank G-d statisticians don’t treat patients. I am still stuck on the brew ha ha over the absence of CR’s and PR’s. Maybe someone can help me here. If LR patients have < 5% blasts, how does one assess a PR...
- Fri Mar 15, 2024 3:28 pm
- Forum: ImetelChat
- Topic: I raise my glass
- Replies: 2
- Views: 1392
I raise my glass
I raise my glass to Fish Sr.and Irish. Wish they could be here to help us celebrate. And of course to John and his team who had the vision to see this through to this point. And to all who have contributed to making this board worthwhile. My thanks and admiration. bp
- Fri Mar 15, 2024 2:49 pm
- Forum: ImetelChat
- Topic: Quite Surprising that....
- Replies: 10
- Views: 3350
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: 1222
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: 1970
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: 1970
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: 1970
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: 1970
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: 2713
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: 1284
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: 1739
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: 1739
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: 1562
- Tue Mar 12, 2024 8:53 pm
- Forum: ImetelChat
- Topic: Geron Responds…
- Replies: 5
- Views: 1562
- Tue Mar 12, 2024 8:12 pm
- Forum: ImetelChat
- Topic: Risk vs. Benefit
- Replies: 6
- Views: 1739
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: 1337
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: 1172
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 ...