A summary of recent thoughts

Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Post Reply
biopearl
Posts: 367
Joined: Wed Dec 09, 2015 12:12 am

A summary of recent thoughts

Post by biopearl » Fri Apr 27, 2018 8:02 pm

A summary of recent thoughts:
1. MF R/R study is closed. Who closed it, Geron? No, Janssen.
2. A key secondary end point of OS was emphasized in recent clinical trials update, by whom, Geron? No Janssen.
3. Imetelstat remains on Janssen's NME list and Janssen has thrown down a claim for domination in the hematologic malignancy arena.
4. Based on previous communications, how long will final analysis take from the closing of the study? 6 weeks to ten weeks (mid-end July). Study doesn't completely end for another year--they anticipate survival in some to continue for a considerable time beyond now, per study addendum.
5. Will they have MDS data on the new 20 enrollees by mid to end of July, yes. (Full enrollment in Feb, Dr. Raza's data:8 weeks median time to drug effect--that's pretty fast + 8 weeks to confirm TI so 16 weeks from Feb+ 4-6 weeks to analyze data. Will they tell us? No, we have to wait for ASH for the data, but they might announce PIII MDS or a new AML study. Will they announce the continuation agreement? Probably, they don't have to wait for ASH or share data for that to happen. Will the FDA act on this data before ASH? Tough one but I am betting yes.
6. Lots of FUD about. From what source? From Geron? No. From Janssen? No.
7. Is closing the study a week early important? Well for me, while I was holding March calls it a day or two could have made a big difference, (thanks a lot John...). Now I have Sept and Dec calls. I'll take the extra week. bp

Post Reply