Search found 1670 matches
- Tue Mar 12, 2024 3:59 pm
- Forum: ImetelChat
- Topic: ADCO comments
- Replies: 5
- Views: 1169
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: 1681
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: 2820
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: 1681
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: 950
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.
- Mon Mar 11, 2024 6:00 pm
- Forum: ImetelChat
- Topic: Finally, disease modification?
- Replies: 4
- Views: 950
- Sun Mar 10, 2024 9:01 pm
- Forum: ImetelChat
- Topic: Additional comments to FDA
- Replies: 10
- Views: 2820
Re: Additional comments to FDA
RC, waaay too sensible. FDA and ADCOM will probably limit approval to submitted data for the applied for indication. What oncologists do after (if) approval is a different story but still think they at least for now will require Lus failure even in high transfusion burden patients before reaching fo...
- Sun Mar 10, 2024 4:10 pm
- Forum: ImetelChat
- Topic: Additional comments to FDA
- Replies: 10
- Views: 2820
- Sat Mar 09, 2024 10:08 pm
- Forum: ImetelChat
- Topic: Taking the temperature at the FDA
- Replies: 5
- Views: 1217
Re: Taking the temperature at the FDA
Thank you CKTC and Ryan, Ryan I don't think it's a case of "someone knows something" but rather general anticipation of a positive outcome from the meeting and the potential PR that will follow. Once the ODAC votes (if positive), and the outcome is made public, actual FDA approval will probably be a...
- Sat Mar 09, 2024 4:20 pm
- Forum: ImetelChat
- Topic: Taking the temperature at the FDA
- Replies: 5
- Views: 1217
Taking the temperature at the FDA
Three days before the ODAC, the FDA will release documents pertinent to that meeting. Should be interesting reading and might give us an idea where any reservations or endorsements lie. As mentioned I will not be able to view the meeting in real time so I hope some board readers will post any releva...
- Thu Mar 07, 2024 5:48 pm
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5780
March 14th
Am tied up with an all day commitment on March 14th so I won’t be posting in real time but will review the meeting once it is archived. Don’t interpret my lack of posting that day as a lack of interest (!!). If anyone can post a distillation of issues discussed and the temperature of the ODAC, it wo...
- Wed Mar 06, 2024 10:08 pm
- Forum: ImetelChat
- Topic: Additional comments to FDA
- Replies: 10
- Views: 2820
Additional comments to FDA
Filed after the “to be made public deadline, but will be still considered by ODAC” was a filing from “ Institute for Clinical and Economic Review”. This entity plans to compare metadata from the Luspatercept studies with IMerge with plans for this evaluation to take place by July 2024. Should be int...
- Mon Mar 04, 2024 9:22 pm
- Forum: ImetelChat
- Topic: Using fingers to count down now
- Replies: 3
- Views: 1435
Re: Using fingers to count down now
Ryan, I have to agree. I think the ODAC meeting may well result in a unanimous (or near unanimous) vote and serve as a spring board for a more public review of the supporting data. It will also provide an inflection point for assessing the value of Geron as a company.
- Sun Mar 03, 2024 6:29 pm
- Forum: ImetelChat
- Topic: Kudos
- Replies: 12
- Views: 2539
Re: Kudos
Well, Jingle, you could be right. May not be as important as it once was. Getting across the finish line is the thing. All help getting there over the years appreciated.
- Sat Mar 02, 2024 11:37 pm
- Forum: ImetelChat
- Topic: Kudos
- Replies: 12
- Views: 2539
Re: Kudos
Might be I have become a revisionist… I will definitely defer to you on this one.
- Sat Mar 02, 2024 8:54 pm
- Forum: ImetelChat
- Topic: Kudos
- Replies: 12
- Views: 2539
Re: Kudos
Sdraw appeared when we all needed reassurance and disappeared when we didn’t. I don’t think health had anything to do with it. But we will never know for sure.
- Sat Mar 02, 2024 3:20 am
- Forum: ImetelChat
- Topic: Kudos
- Replies: 12
- Views: 2539
Re: Kudos
Pure speculation on my part re comments on FDA board.
- Fri Mar 01, 2024 11:32 pm
- Forum: ImetelChat
- Topic: Kudos
- Replies: 12
- Views: 2539
Kudos
Kudos to Stig, you make your fellow board members proud and of course to Sdraw!
- Fri Mar 01, 2024 6:21 am
- Forum: ImetelChat
- Topic: The road to the front of line
- Replies: 2
- Views: 927
The road to the front of line
Geron has always had a strategy. It’s very slow moving in case you haven’t noticed. Even though they may have a unique drug, they chose not to strike at the heart of the king directly. Instead by garnering second line approval which seems highly likely, their strategy appears to see what physician a...
- Fri Mar 01, 2024 12:45 am
- Forum: ImetelChat
- Topic: Big boys get FDA Priority review.....
- Replies: 3
- Views: 913
Re: Big boys get FDA Priority review.....
I agree they should have. I think the compromise will be a much earlier date for approval than the currently listed PDUFA date. If the FDA was true to their commitment to rolling review, then those modules should be reviewed and closed. All that remains is ADCOM: FDA please review and approve. On an...