Search found 430 matches

by biopearl123
Sat Oct 24, 2020 12:18 am
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 5
Views: 388

Re: 4 new sites added to MDS study

Ah, bet crossover allowed only after (and if) early look is significant at which point primary end point would be proven but study would continue. At that point provisional approval could be requested.
by biopearl123
Fri Oct 23, 2020 10:29 pm
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 5
Views: 388

Re: 4 new sites added to MDS study

CKTC, was thinking about your comment re crossover. Clearly allowing crossover is morally correct. But since mortality is the primary endpoint and not some other (admittedly more nebulous endpoint like disease progression), won’t allowing crossover murkify the mortality end point, prolong the study ...
by biopearl123
Fri Oct 23, 2020 10:02 pm
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 5
Views: 388

Re: 4 new sites added to MDS study

CKTC, I missed the crossover allowance, thanks for pointing that out. Finally a study design that might not actually have to go to completion. bp
by biopearl123
Thu Oct 22, 2020 10:29 pm
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 5
Views: 388

4 new sites added to MDS study

Study continues to ramp up. Several sites still "active but not recruiting" but presumably will be in the near future. At this point each site only needs to enroll about 2 patients to get to the finish line. Since we have not yet received confirmation about reaching the 50 % enrollment mark, I would...
by biopearl123
Thu Oct 22, 2020 6:49 pm
Forum: ImetelChat
Topic: Thrombocytopenias
Replies: 2
Views: 306

Re: Thrombocytopenias

Gwikley, this article directly addresses your question. Imetelstat works directly on normal stem cells also and affects megakaryocyte Precursors. It is treated with dose reductions. Fortunately the effects on the malignant stem cell are disproportionate to normal stem Cells. https://www.ncbi.nlm.nih...
by biopearl123
Thu Oct 22, 2020 12:02 am
Forum: ImetelChat
Topic: ASH abstracts
Replies: 6
Views: 1414

Re: ASH abstracts

What a great choice! Dr. Fauci is a man of honor, intellect and a clarion voice of informed honesty. It is a shame he has been subjected to such disrespectful treatment by our current leaders. While we are on the subject of COVID, consider that the latest job posting appears yet to be filled. Probab...
by biopearl123
Mon Oct 19, 2020 3:40 am
Forum: ImetelChat
Topic: New Article
Replies: 2
Views: 2019

Re: New Article

by biopearl123
Sun Oct 18, 2020 8:34 pm
Forum: ImetelChat
Topic: New Article
Replies: 2
Views: 2019

New Article

Novel Concepts of Treatment for Patients with Myelofibrosis and Related Neoplasms Prithviraj Bose * , Lucia Masarova and Srdan Verstovsek Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA; lmasarova@mdanderson.org (L.M.); sverstov@mdanderson.org (S.V.) * C...
by biopearl123
Sun Oct 11, 2020 6:30 pm
Forum: ImetelChat
Topic: Minimal Residual Disease
Replies: 0
Views: 686

Minimal Residual Disease

Be interesting to see if MRD enters the discussion at ASH. Given the unprecedented TI rates and bone marrow regression to normal, its time to have this discussion.
by biopearl123
Sun Oct 11, 2020 2:28 am
Forum: ImetelChat
Topic: Trying to connect dots that may or may not exist and if they do, they move like the three body problem
Replies: 4
Views: 1055

Re: Trying to connect dots that may or may not exist and if they do, they move like the three body problem

rccola, The EU meeting was for MF, not MDS. Don't know if they are assigned different numbers depending on indication. In any case if you want to dig deeper here is the 2015 number assigned to Imetelstat when it was granted OD in 2015. We could be chasing smoke (as usual) but sometimes one can catch...
by biopearl123
Sat Oct 10, 2020 8:02 pm
Forum: ImetelChat
Topic: Re MRD (thank you PEDMAC)
Replies: 0
Views: 445

Re MRD (thank you PEDMAC)

https://www.tandfonline.com/doi/full/10 ... 20.1831381

Remember Geron has an expert on MRD on board.
by biopearl123
Sat Oct 10, 2020 4:51 am
Forum: ImetelChat
Topic: Trying to connect dots that may or may not exist and if they do, they move like the three body problem
Replies: 4
Views: 1055

Re: Trying to connect dots that may or may not exist and if they do, they move like the three body problem

Thanks rccola I wondered but didn’t have time to go back and check. Thanks for doing that. bp
by biopearl123
Fri Oct 09, 2020 6:35 pm
Forum: ImetelChat
Topic: Trying to connect dots that may or may not exist and if they do, they move like the three body problem
Replies: 4
Views: 1055

Trying to connect dots that may or may not exist and if they do, they move like the three body problem

Recently the COMP met to discuss a drug for "discussion and opinion" identified as EMA OD/0000036404 for R/R MF. I don't know if this is Imetelstat or not but there are not a lot of drugs in this category and I supposed it is unnamed for a reason. We know that OD was granted in this indication in 20...
by biopearl123
Thu Oct 08, 2020 9:04 pm
Forum: ImetelChat
Topic: For your consideration
Replies: 1
Views: 584

Re: For your consideration

Repost from YMB: PEDMAC2000, This article highlights something that is in front of everyone's eyes but cannot be seen (the eye can not see what the mind does not know). When the Janssen study was underway there was a high drop out rate. Why? because patients and doctors did not see the promised sple...
by biopearl123
Thu Oct 08, 2020 9:02 pm
Forum: ImetelChat
Topic: For your consideration
Replies: 1
Views: 584

For your consideration

by biopearl123
Tue Oct 06, 2020 8:34 pm
Forum: ImetelChat
Topic: Why would GERN need $75M facility?
Replies: 4
Views: 1565

Re: Why would GERN need $75M facility?

Love your hypothesis but Geron sold this on the cheap a long time ago while retaining a small royalty potential.
by biopearl123
Tue Oct 06, 2020 3:51 am
Forum: ImetelChat
Topic: The potential loan package....?
Replies: 6
Views: 1984

Re: The potential loan package....?

HI, interesting. Re #1, the same delays in recruitment that the MDS and MF trials face would apply, but I would love to see the AML study get off the ground. #2 I hope the timelines do not need to be extended but clearly the effects of COVID can not be underestimated. Re # 3, given the extensive pat...
by biopearl123
Mon Oct 05, 2020 4:53 am
Forum: ImetelChat
Topic: The potential loan package....?
Replies: 6
Views: 1984

Re: The potential loan package....?

Hi Ashah, If a partner or approval were close, the company could anticipate income and would not need the loan. So I am forced to conclude neither is happening soon. Also the 9 % rate is not exactly one the indicates the bank thinks this is a low risk loan. Since we know a PIP has not yet been grant...
by biopearl123
Sat Oct 03, 2020 6:32 am
Forum: ImetelChat
Topic: The potential loan package....?
Replies: 6
Views: 1984

Re: The potential loan package....?

Hi Ashah, I am not sure getting a 9 % rate in this era of low interest is so great. I don’t think Geron has some bombshell to drop. More likely I think we will see that enrollment time lines will be pushed out due to COVID and the loan will ensure completion of the PIII studies. The need for it cont...
by biopearl123
Thu Oct 01, 2020 2:23 am
Forum: ImetelChat
Topic: ASH abstracts
Replies: 6
Views: 1414

Re: ASH abstracts

Zhears, right you are, have never seen that kind of statement before. Usual Acknowledgement of acceptance Of abstract/poster early Oct. Release of title and abstract usually early November. Not sure what Dr Scarletts statement implies, either he was very sure of likelihood of acceptance or he alread...