Search found 430 matches

by biopearl123
Tue Jul 07, 2020 4:34 pm
Forum: ImetelChat
Topic: Use of RWD for frontline MF approval
Replies: 4
Views: 2283

Re: Use of RWD for frontline MF approval

Hi Ashah, I think the answer lies in Geron needing data to differentiate it from Luspatercept which they now clearly have. bp
by biopearl123
Mon Jul 06, 2020 9:38 pm
Forum: ImetelChat
Topic: Use of RWD for frontline MF approval
Replies: 4
Views: 2283

Re: Use of RWD for frontline MF approval

Ashah, I think your question re EU becomes even more relevant and prescient given recent events. Even if the EU does not value RWD in the same way we had hoped the FDA would (and as they seemed to indicate via various guideline papers they published), it does appear that after orphan status is grant...
by biopearl123
Fri Jul 03, 2020 6:56 pm
Forum: ImetelChat
Topic: Request for Imetelchat Board thoughts
Replies: 8
Views: 3059

Re: Request for Imetelchat Board thoughts

Lekola, have thought about your questions and have some preliminary thoughts. First off, happy Fourth to all board members we are most fortunate to be part of this country despite or perhaps because of its many problems. My father was a WW II vet also (medical corps) in the Philippines. He once said...
by biopearl123
Thu Jul 02, 2020 11:56 pm
Forum: ImetelChat
Topic: EU orphan status
Replies: 12
Views: 3568

Re: EU orphan status

Hi Ryan, right. Its deja vu all over again. 5 years ago I suspect Janssen thought they had an MA sown up for MF, 1. Unmet medical need 2. Requisite small treatable patient population 3. Plans for confirmatory data AND wait for it-- good PII data--NOT. As we know this one check box was not ticked and...
by biopearl123
Thu Jul 02, 2020 12:24 am
Forum: ImetelChat
Topic: EU orphan status
Replies: 12
Views: 3568

Re: EU orphan status

Considering that orphan designation was granted for MF in Dec of 2015 without subsequent market authorization one can only hope the EU will grant MA for both indications (finally) based on the link provided by rucola335. Of course I thought we would see positive movement five years ago when the MF o...
by biopearl123
Wed Jul 01, 2020 11:45 pm
Forum: ImetelChat
Topic: EU orphan status
Replies: 12
Views: 3568

Re: EU orphan status

rccola335, thanks for the link. My sense is that Geron has little interest in fostering compassionate use (to their discredit). But the following from the link you kindly provided is intesting: "Conditional marketing authorisations may be granted if the CHMP finds that all the following requirements...
by biopearl123
Wed Jul 01, 2020 10:24 pm
Forum: ImetelChat
Topic: EU orphan status
Replies: 12
Views: 3568

Re: EU orphan status

rccola335, I confess to not knowing enough about the EU approval process, can you elaborate? It does seem that orphan status was granted later than in the US. Made me wonder if they wanted to "start the clock" as late as possible as to extend the potential benefits. bp
by biopearl123
Sun Jun 28, 2020 4:08 pm
Forum: ImetelChat
Topic: Hat tip to Cheng Ho
Replies: 3
Views: 1707

Re: Hat tip to Cheng Ho

by biopearl123
Fri Jun 26, 2020 10:52 pm
Forum: ImetelChat
Topic: Hat tip to Cheng Ho
Replies: 3
Views: 1707

Re: Hat tip to Cheng Ho

bucbeard, If the FDA didn't grant on the basis of the extraordinary TN data, the MOS/molecular end point data, the heretofore unknown TI duration, I don't think they will grant on the basis of anything beside convincing PIII data. bp
by biopearl123
Fri Jun 26, 2020 7:18 pm
Forum: ImetelChat
Topic: Hat tip to Cheng Ho
Replies: 3
Views: 1707

Hat tip to Cheng Ho

by biopearl123
Fri Jun 26, 2020 12:51 am
Forum: ImetelChat
Topic: Combination Therapy vs. Radiation
Replies: 0
Views: 1308

Combination Therapy vs. Radiation

We have all seen promising preclinical work with combinations which has resulted in a clamor and a scratching of heads as to why this apparently has not been pursued. There has been the Yale study, as well as combinations with Venotoclax for AML, and the Rux sequential study to name a few. There has...
by biopearl123
Thu Jun 25, 2020 9:27 pm
Forum: ImetelChat
Topic: Hat tip to Bill W Cheng Ho
Replies: 3
Views: 1592

Re: Hat tip to Bill W Cheng Ho

Thank you smikhail. And Bill thanks for clarifying. Credit should be given where credit is due. bp
by biopearl123
Tue Jun 23, 2020 8:20 pm
Forum: ImetelChat
Topic: Request for Imetelchat Board thoughts
Replies: 8
Views: 3059

Re: Request for Imetelchat Board thoughts

Lekola, maybe another way to look at is via the GOAT, Groucho (Duck Soup maybe? ) who said, "Who are you going to believe me or your lying' eyes"? When you look at the 4 recent EHA presentations there are close to 100 authors (with a lot of overlap so lets call it 20 experts), each with first hand e...
by biopearl123
Tue Jun 23, 2020 8:07 pm
Forum: ImetelChat
Topic: Hat tip to Bill W Cheng Ho
Replies: 3
Views: 1592

Hat tip to Bill W Cheng Ho

Bill provided the link to this recent article: http://pubmed.ncbi.nlm.nih.gov/32571117/

kamall (wherever your are--hopefully on the high COVID free seas with a cold beer in hand) has discussed a possible Japanese connection in previous posts. bp
by biopearl123
Mon Jun 22, 2020 5:09 am
Forum: ImetelChat
Topic: Timeline for approval
Replies: 1
Views: 1366

Timeline for approval

CKTC and HI, thank you for posting. Very disappointing after the FDA articles re RWD that Geron could not have been a test case (but still might be in other future indications per your post). What are your thoughts re the most optimistic timeline for approval? Since Dr. Scarlett has guided that appr...
by biopearl123
Sun Jun 21, 2020 8:46 pm
Forum: ImetelChat
Topic: Request for Imetelchat Board thoughts
Replies: 8
Views: 3059

Re: Request for Imetelchat Board thoughts

Hi Lekola, hope you are well and healthy. Jacosa is really smart and has been right about a lot of things about Incyte and has also been right about a lot of things Geron over the years. But Rux does probably not prolong life except to the extend that anorexia and overall sense of well being might b...
by biopearl123
Sat Jun 20, 2020 8:34 pm
Forum: ImetelChat
Topic: How many members of the Scientific Program Committee for EHA are from the US
Replies: 0
Views: 1387

How many members of the Scientific Program Committee for EHA are from the US

None. That's fair, it's a European meeting. All 22 members are non US. But politics, academic rivalry etc are not bound by the seas. In any case, AHA is is December. Dr. Mascarenhas is a feisty New Yorker and a first class clinical investigator and he will be heard. We will finally likely see an ora...
by biopearl123
Thu Jun 18, 2020 9:26 pm
Forum: ImetelChat
Topic: Excellent KOL presentation
Replies: 2
Views: 1531

Re: Excellent KOL presentation

As the information from the EHA and KOL percolates into the financial sector, it is pretty clear that Geron's Imetelstat occupies its own space with no significant competition in the high transfusion requirement, low risk MDS sector and the MF sector re significant life extension. The physician cham...