Search found 1666 matches
- Wed Feb 14, 2024 3:58 pm
- Forum: ImetelChat
- Topic: Will NOAA take action while the FDA stands on the sidelines?
- Replies: 14
- Views: 1875
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: 1875
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: 1495
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: 1495
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: 1350
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: 1350
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: 31
- Views: 6880
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: 31
- Views: 6880
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: 31
- Views: 6880
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: 31
- Views: 6880
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: 1006
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: 31
- Views: 6880
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: 1469
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: 1033
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: 577
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: 1033
- Tue Feb 06, 2024 6:45 pm
- Forum: ImetelChat
- Topic: Novartis and Morphosys
- Replies: 9
- Views: 1793
Re: Novartis and Morphosys
That is crazy interesting. I think the door to Dr. Scarlett's office may remain open. What are your thoughts about the IMPRESS study update? This study was supposed to set the stage for understanding the proper dose for a combination study. Clinical trials: "Overall Hematological Response Rate of Pa...
- Tue Feb 06, 2024 3:59 pm
- Forum: ImetelChat
- Topic: Impress Study
- Replies: 3
- Views: 1166
- Tue Feb 06, 2024 3:51 pm
- Forum: ImetelChat
- Topic: Impress Study
- Replies: 3
- Views: 1166
Impress Study
The Impress study top line data release has been extended by a little over a year to Feb 2025. As I recall the end point was ORR. We know enrollment was at 50% in November. Be nice to have some clarification here. Patients enrolled in this study were left with few options. Why wait another year to r...
- Tue Feb 06, 2024 3:07 pm
- Forum: ImetelChat
- Topic: Novartis and Morphosys
- Replies: 9
- Views: 1793
Re: Novartis and Morphosys
Thanks Kmall, Pelabresib along with Rux still seems to keep the focus on the spleen. And yes, not having to carry a bag of blood around in your left upper quadrant probably improves patient comfort by a lot, overall symptoms don’t seem to be impacted, hard to feel well with a disease like that. Agai...