Search found 50 matches
- Mon Sep 07, 2020 6:09 pm
- Forum: ImetelChat
- Topic: Recent ATM
- Replies: 5
- Views: 3668
Re: Recent ATM
You have to be careful when interpreting the market size of patients with MDS-RS (RARS). Technically, to be considered MDS-RS, the bone marrow must have greater than 15% of erythroid precursors with ringed sideroblasts, or 5% in the presence of an SF3B1 mutation. So yes, it has been estimated that u...
- Sun Sep 06, 2020 6:31 pm
- Forum: ImetelChat
- Topic: Recent ATM
- Replies: 5
- Views: 3668
Re: Recent ATM
Another challenge with enrollment is the approval of luspatercept (FDA Nov/2019, EMA Apr/2020). Sales have ramped up very quickly ($55 million 2nd qtr. 2020). Many doctors will want to give their patients a shot at luspatercept first before putting them into a trial where one in three will be gettin...
- Sat Sep 05, 2020 6:53 pm
- Forum: ImetelChat
- Topic: Orphan being discussed AML/MDS/JMML
- Replies: 9
- Views: 5584
Re: Orphan being discussed AML/MDS/JMML
@biopearl123 Without having to research this ( which I have no interest in doing), I think what you are seeing is the PDCO notice of a discussion on Geron’s application for a pediatric investigation plan (PIP) wavier for imetelstat in MDS/AML. Janssen received a similar waiver for imetelstat in MF (...
- Wed Jul 15, 2020 4:00 am
- Forum: ImetelChat
- Topic: New BOD representation
- Replies: 4
- Views: 2782
Re: New BOD representation
These types of purchase limitations in secondary offerings prevent any one investor from securing too much influence – at a discount. An investor can always go into the open market and acquire enough shares at market price to challenge management. I’m sure these investors would, as you say, wish to ...
- Tue Jul 14, 2020 8:47 pm
- Forum: ImetelChat
- Topic: New BOD representation
- Replies: 4
- Views: 2782
Re: New BOD representation
The way the recent offering was structured, there was a limitation on exercise preventing any of the participating investors from beneficially owning in excess of 9.99% of the number of shares of Geron’s common stock outstanding – including warrants, which all three of the buyers below exercised ful...
- Tue Jun 23, 2020 1:51 pm
- Forum: ImetelChat
- Topic: Timeline for approval
- Replies: 1
- Views: 2452
Re: Timeline for approval
The Phase 3 MDS trial will need to run its course. There’s nothing Geron can do to speed access to the data other than speeding up patient enrollment. But there’s a lot the company can do to speed up the approval timeline as Fast Track status allows for “Rolling” submissions and “Priority” review. I...
- Sun Jun 21, 2020 11:07 pm
- Forum: ImetelChat
- Topic: Request for Imetelchat Board thoughts
- Replies: 8
- Views: 6278
Re: Request for Imetelchat Board thoughts
Jacosa is correct in that thus far, Incyte's game plan has been to look for ways to extend a patient's response time to ruxolitinib. To this end, the company itself and numerous other sponsors have, for years, been testing ruxolitinib combinations. I count twenty-three combination trials active, and...
- Thu Jun 18, 2020 2:05 pm
- Forum: ImetelChat
- Topic: Hindsight
- Replies: 2
- Views: 2271
Re: Hindsight
Incyte’s Jakafi (ruxolitinib) did $1.7 billion in annual sales in 2019, principally in one indication - myelofibrosis. Incyte expects Jakafi to become a $3 billion brand eventually. There are no approved treatments for refractory myelofibrosis. This market will be lucrative for Geron if imetelstat i...
- Wed Jun 17, 2020 11:02 pm
- Forum: ImetelChat
- Topic: Upcoming Phase 3 MF Trial
- Replies: 4
- Views: 3591
Re: Upcoming Phase 3 MF Trial
To add a little color to my comment above, Dr. Verstovek has been the Principal Investigator on seven ruxolitinib trials that enrolled over 800 patients, including the Phase 3 studies that won Incyte FDA approval for the drug in Myelofibrosis and Polycythemia Vera. He’s been the lead author on score...
- Wed Jun 17, 2020 4:31 pm
- Forum: ImetelChat
- Topic: Upcoming Phase 3 MF Trial
- Replies: 4
- Views: 3591
Upcoming Phase 3 MF Trial
WOW! Dr. Srdan Verstovsek from MD Andersen, the Principal Investigator for Incyte’s COMFORT Phase 3 MF ruxolitinib trial, and the man I call “Dr. Ruxolitinib” as he historically has been the primary apologist for everything related to the drug, is going to be the co-Principal Investigator with Dr. M...