Search found 1670 matches
- Sat Feb 17, 2024 5:21 pm
- Forum: ImetelChat
- Topic: meanwhile, back on topic
- Replies: 25
- Views: 4148
Re: meanwhile, back on topic
Jay I have only seen recent options awarded but not redeemed. I probably missed the ones that were redeemed can you remind us? Thanks, bp
- Wed Feb 14, 2024 7:12 pm
- Forum: ImetelChat
- Topic: meanwhile, back on topic
- Replies: 25
- Views: 4148
Re: meanwhile, back on topic
Thanks Jay, course corrections always appreciated.
- Wed Feb 14, 2024 6:07 pm
- Forum: ImetelChat
- Topic: Will NOAA take action while the FDA stands on the sidelines?
- Replies: 14
- Views: 1994
Re: Will NOAA take action while the FDA stands on the sidelines?
I am good for it, send by seagull?
- Wed Feb 14, 2024 5:11 pm
- Forum: ImetelChat
- Topic: Will NOAA take action while the FDA stands on the sidelines?
- Replies: 14
- Views: 1994
Re: Will NOAA take action while the FDA stands on the sidelines?
Waddya mean you’d bet a dollar, you already owe me a dollar, oh wait maybe I owe you the dollar, can’t remember. Nevermind.
- Wed Feb 14, 2024 3:58 pm
- Forum: ImetelChat
- Topic: Will NOAA take action while the FDA stands on the sidelines?
- Replies: 14
- Views: 1994
Re: Will NOAA take action while the FDA stands on the sidelines?
Kmall, pretty sure Dr. Scarlett starts his day with a cup of coffee and a visit to this board. It is highly likely your concerns well be viewed by him and considered. He of all people has the means and interest.
- Wed Feb 14, 2024 7:16 am
- Forum: ImetelChat
- Topic: Will NOAA take action while the FDA stands on the sidelines?
- Replies: 14
- Views: 1994
Re: Will NOAA take action while the FDA stands on the sidelines?
I actually found the information regarding horseshoe crabs pretty interesting and in truth was unaware of how their blood was harvested and what it is used for. I think looking at the power of the FDA from as many angles as possible is instructive and this is a good example. And that’s why Geron wil...
- Mon Feb 12, 2024 10:16 pm
- Forum: ImetelChat
- Topic: Everyone catch this one last night?
- Replies: 5
- Views: 1556
Re: Everyone catch this one last night?
It’s not quite Apple’s 1984 hammer throw but still pretty pretty good:
https://m.youtube.com/watch?v=riH5EsGcmTw
https://m.youtube.com/watch?v=riH5EsGcmTw
- Mon Feb 12, 2024 4:09 pm
- Forum: ImetelChat
- Topic: Everyone catch this one last night?
- Replies: 5
- Views: 1556
Re: Everyone catch this one last night?
So Pfizer, where’s the beef?
- Sun Feb 11, 2024 7:01 am
- Forum: ImetelChat
- Topic: multiple myeloma ?
- Replies: 6
- Views: 1403
Re: multiple myeloma ?
RC, of course it’s ok to answer your own posts, I seem to do it all the time! In thinking about this I think this article represents an understandable confusion on the part of the journalist. The distinction between MM, AML, various other hematopoietic disorders is hard enough for us to keep straigh...
- Sun Feb 11, 2024 4:17 am
- Forum: ImetelChat
- Topic: multiple myeloma ?
- Replies: 6
- Views: 1403
Re: multiple myeloma ?
RC, you come up with some pretty pretty good stuff! And Kmall, thank you again for all of the important contributions you make to this board. Re MM: There is not active study investigating MM, at least in the public domain. This could be a well meaning journalist who did not dig deeply enough or it ...
- Fri Feb 09, 2024 10:34 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 9892
Re: FDA v. Geron
Jay, they are treated differently, that's for sure but I think they are part of a spectrum of the a single disease that has to start somewhere but evolves on different timelines, perhaps driven by different factors such as associated inflammation, genetic signatures, age etc.
- Fri Feb 09, 2024 8:25 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 9892
Re: FDA v. Geron
Jay, to clarify, my limited understanding of the classification system as to "risk", reflects the predictive value of determining what the risk of progression to high risk/AML is, it is not necessarily a reflection of what the transfusion burden is. The study did enroll patients in the categories yo...
- Fri Feb 09, 2024 5:26 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 9892
Re: FDA v. Geron
Jay, it’s a bit semantic, IPSS seems to be periodically revised. Technically, the study also includes very low risk patients I think. The important point is that Geron is going to the FDA for approval in the exact patient populations outlined in the study. I don’t see any indication they are trying ...
- Fri Feb 09, 2024 4:53 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 9892
Re: FDA v. Geron
Jay, that’s how the study reads on clinical trials site:
“ Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)”. Geron is seeking approval for a well defined exact indication.
“ Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)”. Geron is seeking approval for a well defined exact indication.
- Fri Feb 09, 2024 7:11 am
- Forum: ImetelChat
- Topic: new study
- Replies: 3
- Views: 1062
Re: new study
RC, thanks for posting this. I doubt this study could be conceived without information shared from the as yet undisclosed and unpublished single agent IMPRESS study. Glad to see things moving forward.
- Fri Feb 09, 2024 7:07 am
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 9892
Re: FDA v. Geron
KT, I have to agree with Ashah and LWS. The FDA clearly has a mandate and they will take steps to be sure they fulfill it, including talking with experts, families and patients. This is a totally new med. Potential reasons for denial are out there I suppose but the pluses are pretty strong in favor ...
- Thu Feb 08, 2024 7:06 pm
- Forum: ImetelChat
- Topic: January Presentation
- Replies: 4
- Views: 1596
Re: January Presentation
Ryan, the ODAC votes with a non binding recommendation to the FDA. The voting count is made public but it may not be on the same day especially if the committee needs time to deliberate or asks for more info. We should get a sense how the vote will go during the proceedings. The FDA usually follows ...
- Thu Feb 08, 2024 12:35 am
- Forum: ImetelChat
- Topic: Magro again
- Replies: 4
- Views: 1093
Re: Magro again
Guys, thanks for posting. It will be very interesting to see who the FDA asks to be on the ADCOM.
- Wed Feb 07, 2024 11:53 pm
- Forum: ImetelChat
- Topic: Board Readership
- Replies: 0
- Views: 770
Board Readership
Board readership has increased recently by about 10 fold largely I guess due to anticipation for the FDA ADCOM which will be available to view in real time on March 14th. As regular board readers know we have been plagued by thousands of bot requests for posting privileges. This has been a bit of a ...
- Wed Feb 07, 2024 9:06 pm
- Forum: ImetelChat
- Topic: Magro again
- Replies: 4
- Views: 1093