Search found 1665 matches
- Mon Mar 11, 2024 6:00 pm
- Forum: ImetelChat
- Topic: Finally, disease modification?
- Replies: 4
- Views: 852
- Sun Mar 10, 2024 9:01 pm
- Forum: ImetelChat
- Topic: Additional comments to FDA
- Replies: 10
- Views: 2623
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: 2623
- Sat Mar 09, 2024 10:08 pm
- Forum: ImetelChat
- Topic: Taking the temperature at the FDA
- Replies: 5
- Views: 1136
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: 1136
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: 5441
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: 2623
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: 1342
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: 2422
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: 2422
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: 2422
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: 2422
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: 2422
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: 881
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: 866
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...
- Thu Feb 29, 2024 10:57 pm
- Forum: ImetelChat
- Topic: Big boys get FDA Priority review.....
- Replies: 3
- Views: 866
Re: Big boys get FDA Priority review.....
In fairness to the FDA, if there is such a thing, these drugs are already approved for other indications.
- Thu Feb 29, 2024 3:21 pm
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1553
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Point taken, a black box warning is not the end of the world for Imetelstat and would probably not impair appropriate usage of the drug. In my area, drugs like amiodarone, Sotolol, even digitalis would kill in the hands of the inexperienced. Oncologists use very strong drugs and Imetelstat would not...
- Thu Feb 29, 2024 5:10 am
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1553
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Pretty scary, that example. No doubt the analysts have financial models with and without the black box warnings and are very interested in whether one might be issued. Considering that a black box warning is conferred when there is are serious adverse reactions that “may lead to death or serious inj...
- Thu Feb 29, 2024 12:47 am
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1553
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Operation Kmall was a Herculean undertaking and was a great success lo those many years ago. Our service men deserve the best of care, not to mention the highest respect. When I see a Gold Star family disrespected or a national hero and fine person who has served our country on so many levels like J...
- Wed Feb 28, 2024 11:25 pm
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1553
Absolutely fabulous comments from Dr. Jeffrey Savidge
Eloquent, heartfelt, sincere and well informed. Worth a visit to the FDA comments board to review this. Major kudos, sir. On another note, Just a reminder that the cytopenias are not related to toxicity like many chemo agents, this drug does not destroy the bone marrow, it heals it. It’s pretty stra...