Search found 17 matches

by CKTC
Sun Nov 22, 2020 3:38 pm
Forum: ImetelChat
Topic: Enrollment
Replies: 5
Views: 903

Re: Enrollment

To refine my statements above and more accurately compare apples to apples, cumulative duration of TI, defined as the sum of all periods of 8 week TI during treatment, was a median of 92.3 weeks for imetelstat and 79.9 weeks for luspatercept. To be fair to Scarlett, technically, he is correct that o...
by CKTC
Sat Nov 21, 2020 4:39 pm
Forum: ImetelChat
Topic: Enrollment
Replies: 5
Views: 903

Re: Enrollment

Scarlett has been downplaying the competitive threat of luspatercept for years. And he’s been disingenuous in a number of ways when comparing imetelstat to luspatercept. The most glaring example is his characterization of transfusion independence durability. Scarlett likes to quote imetelstat’s medi...
by CKTC
Wed Nov 11, 2020 4:11 am
Forum: ImetelChat
Topic: The curious case of the abstracts that didn't bark
Replies: 11
Views: 1579

Re: The curious case of the abstracts that didn't bark

In addition to UT running an enormous MPN research operation, Tefferi is probably one of the reasons Mesa left Mayo for UT after being at Mayo his entire career, including medical school.
by CKTC
Sun Nov 08, 2020 9:24 pm
Forum: ImetelChat
Topic: The curious case of the abstracts that didn't bark
Replies: 11
Views: 1579

Re: The curious case of the abstracts that didn't bark

@biopearl, It is painfully apparent many patients came off imetelstat too early. Imetelstat is a potent drug whose benefits can linger long after discontinuation. If there is a conscious effort on the part of investigators to not “emphasize” those lingering benefits, it might have to do with salvage...
by CKTC
Sun Nov 08, 2020 4:40 pm
Forum: ImetelChat
Topic: The curious case of the abstracts that didn't bark
Replies: 11
Views: 1579

Re: The curious case of the abstracts that didn't bark

Speaking of KOL’s, I noted in a 6/17 post, Srdan Verstovsek (Dr. “Ruxolitinib”) of MD Anderson will be co-Principal Investigator with John Mascarenhas of Ichan School of Medicine for the upcoming Phase 3 IMpactMF trial. Dr. Verstovek was Principal Investigator for Incyte’s Phase 3 COMFORT trial that...
by CKTC
Sat Oct 24, 2020 4:07 pm
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 6
Views: 1417

Re: 4 new sites added to MDS study

Here's the exact wording: "Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval." Allowing a crossover is more appealing, both ethically and from a recruitment standpoint. But it creates challenges in trial res...
by CKTC
Fri Oct 23, 2020 7:36 pm
Forum: ImetelChat
Topic: 4 new sites added to MDS study
Replies: 6
Views: 1417

Re: 4 new sites added to MDS study

If they truly haven’t gotten to the half-way point yet, this is going to take forever to enroll. At this rate, they could fully enroll the new MF trial before the MDS trial. BTW, the new MF trial is interesting. They’re allowing a crossover from the Comparator Arm to the Imtetelstat Arm upon disease...
by CKTC
Mon Sep 07, 2020 6:09 pm
Forum: ImetelChat
Topic: Recent ATM
Replies: 5
Views: 1892

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...
by CKTC
Sun Sep 06, 2020 6:31 pm
Forum: ImetelChat
Topic: Recent ATM
Replies: 5
Views: 1892

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...
by CKTC
Sat Sep 05, 2020 6:53 pm
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2512

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 (...
by CKTC
Wed Jul 15, 2020 4:00 am
Forum: ImetelChat
Topic: New BOD representation
Replies: 4
Views: 1497

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 ...
by CKTC
Tue Jul 14, 2020 8:47 pm
Forum: ImetelChat
Topic: New BOD representation
Replies: 4
Views: 1497

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...
by CKTC
Tue Jun 23, 2020 1:51 pm
Forum: ImetelChat
Topic: Timeline for approval
Replies: 1
Views: 1465

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...
by CKTC
Sun Jun 21, 2020 11:07 pm
Forum: ImetelChat
Topic: Request for Imetelchat Board thoughts
Replies: 8
Views: 3331

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...
by CKTC
Thu Jun 18, 2020 2:05 pm
Forum: ImetelChat
Topic: Hindsight
Replies: 2
Views: 1315

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...
by CKTC
Wed Jun 17, 2020 11:02 pm
Forum: ImetelChat
Topic: Upcoming Phase 3 MF Trial
Replies: 4
Views: 1935

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...
by CKTC
Wed Jun 17, 2020 4:31 pm
Forum: ImetelChat
Topic: Upcoming Phase 3 MF Trial
Replies: 4
Views: 1935

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...