Search found 1665 matches

by biopearl123
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?
by biopearl123
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...
by biopearl123
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…:)
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...
by biopearl123
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.
by biopearl123
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.
by biopearl123
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...
by biopearl123
Tue Mar 12, 2024 9:26 pm
Forum: ImetelChat
Topic: Geron Responds…
Replies: 5
Views: 1461

Re: Geron Responds…

by biopearl123
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...
by biopearl123
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...
by biopearl123
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 ...
by biopearl123
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...
by biopearl123
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.
by biopearl123
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’ ...
by biopearl123
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...
by biopearl123
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.