ImetelChat

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.

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’ ...

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...

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.

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...

https://www.regulations.gov/comment/FDA ... -0016-0012

Another heartfelt comment

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...

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...

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...

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...

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.

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.

Might be I have become a revisionist… I will definitely defer to you on this one.

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.

Pure speculation on my part re comments on FDA board.

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

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...

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...

In fairness to the FDA, if there is such a thing, these drugs are already approved for other indications.