Search found 1665 matches

by biopearl123
Wed Feb 14, 2024 7:16 am
Forum: ImetelChat
Topic: Will NOAA take action while the FDA stands on the sidelines?
Replies: 14
Views: 1873

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...
by biopearl123
Mon Feb 12, 2024 10:16 pm
Forum: ImetelChat
Topic: Everyone catch this one last night?
Replies: 5
Views: 1493

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
by biopearl123
Mon Feb 12, 2024 4:09 pm
Forum: ImetelChat
Topic: Everyone catch this one last night?
Replies: 5
Views: 1493

Re: Everyone catch this one last night?

So Pfizer, where’s the beef?
by biopearl123
Sun Feb 11, 2024 7:01 am
Forum: ImetelChat
Topic: multiple myeloma ?
Replies: 6
Views: 1349

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...
by biopearl123
Sun Feb 11, 2024 4:17 am
Forum: ImetelChat
Topic: multiple myeloma ?
Replies: 6
Views: 1349

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 ...
by biopearl123
Fri Feb 09, 2024 10:34 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6825

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.
by biopearl123
Fri Feb 09, 2024 8:25 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6825

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...
by biopearl123
Fri Feb 09, 2024 5:26 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6825

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 ...
by biopearl123
Fri Feb 09, 2024 4:53 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6825

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.
by biopearl123
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.
by biopearl123
Fri Feb 09, 2024 7:07 am
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6825

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 ...
by biopearl123
Thu Feb 08, 2024 7:06 pm
Forum: ImetelChat
Topic: January Presentation
Replies: 4
Views: 1468

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 ...
by biopearl123
Thu Feb 08, 2024 12:35 am
Forum: ImetelChat
Topic: Magro again
Replies: 4
Views: 1031

Re: Magro again

Guys, thanks for posting. It will be very interesting to see who the FDA asks to be on the ADCOM.
by biopearl123
Wed Feb 07, 2024 11:53 pm
Forum: ImetelChat
Topic: Board Readership
Replies: 0
Views: 576

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 ...
by biopearl123
Tue Feb 06, 2024 6:45 pm
Forum: ImetelChat
Topic: Novartis and Morphosys
Replies: 9
Views: 1790

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...
by biopearl123
Tue Feb 06, 2024 3:51 pm
Forum: ImetelChat
Topic: Impress Study
Replies: 3
Views: 1164

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...
by biopearl123
Tue Feb 06, 2024 3:07 pm
Forum: ImetelChat
Topic: Novartis and Morphosys
Replies: 9
Views: 1790

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...
by biopearl123
Tue Feb 06, 2024 3:25 am
Forum: ImetelChat
Topic: Novartis and Morphosys
Replies: 9
Views: 1790

Re: Novartis and Morphosys

Kamall, yes, there have been claims of symptom improvement and perhaps disease modification but so far I have only seen the goal of OS pursued by Geron. Don't remember if pelabresib data included an assessment of bone marrow fibrosis improvement. When I have time I will go back and look unless anyon...