Search found 1665 matches

by biopearl123
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...
by biopearl123
Sun Mar 10, 2024 4:10 pm
Forum: ImetelChat
Topic: Additional comments to FDA
Replies: 10
Views: 2623

Re: Additional comments to FDA

by biopearl123
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...
by biopearl123
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...
by biopearl123
Thu Mar 07, 2024 5:48 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5442

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...
by biopearl123
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...
by biopearl123
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.
by biopearl123
Sun Mar 03, 2024 6:29 pm
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2423

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.
by biopearl123
Sat Mar 02, 2024 11:37 pm
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2423

Re: Kudos

Might be I have become a revisionist… I will definitely defer to you on this one.
by biopearl123
Sat Mar 02, 2024 8:54 pm
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2423

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.
by biopearl123
Sat Mar 02, 2024 3:20 am
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2423

Re: Kudos

Pure speculation on my part re comments on FDA board.
by biopearl123
Fri Mar 01, 2024 11:32 pm
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2423

Kudos

Kudos to Stig, you make your fellow board members proud and of course to Sdraw!
by biopearl123
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...
by biopearl123
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...
by biopearl123
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.
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...
by biopearl123
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...