ImetelChat

From YMB PEDMAC2000's response to a query of Geron: "While the two seem inter-related, it’s really a matter of closing out a previous study in neuroblastoma, and ongoing dialogue with the European Medicines Agency’s Pediatric Committee (PDCO). As I am sure you are aware, both the EMA and the U.S. Fo...

As we continue to assess the potential competition for Imetelstat, the back drop of recent high volume in the market can not be ignored. Friday when the final tally was complete, it was a 35 M volume day, about 10 times the usual daily volume. We have seen recent acquisition activity and large expen...

Make that 25 B

Ashah, I wouldn't hold your breath, Gilead just spent a combined 20B on acquisitions. Doubt they have any interest in Geron.

There has been a lot of discussion on SA and YMB regarding the Gilead (nee Forty Seven) CD 47/Azacitidine Ib study that has been expanded to include lower risk MDS. I am starting to look a studies to try to asses whether this combination could "leap frog" Imetelstat. I found this in one of Dr. Irvin...

https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.7507 Ryan saw your response on YMB and found it reassuring but not sure it comports with what I am seeing here. Can you help parse this out? Clearly the study cited is a different population than the lower risk MDS Geron PIII but it is notabl...

Magrolimab mono therapy or Magrolimab in combination with Azacitidine in patients with hematological malignancies: Study expanded from 96 patients to to 257. Additional primary end point added: 8 week TI in patients with low risk MDS. Additional thoughts: CD 47 is expressed as disease progress with ...

Gilead's recently acquired Forty Seven Pharma magrolimab received Breakthrough Designation (in combination with Azacytidine) from the FDA today based on 1b data. Indication is intermediate, high risk and very high risk MDS. While not quite the same population as low and int risk targeted by Geron, t...

Today's (pending as of now) Wainright presentation contains a slide indicating an "unchecked box" relating to the upcoming ASH meeting in December (they will almost certainly be virtual). The usual accept/reject dates for abstracts is early October. Yet we see an indication that Geron data updates a...

A site in Israel and in Germany were added per update today. The primary completion date has not (yet) been altered. Interestingly about 10% of the clinical sites are in Israel when has a particularly high COVID rate right now. We have apparently not yet reached the 50% enrollment mark yet. Dr. Scar...

To put a point on CKTCs comments, it seems likely that in light of the ready adoption of Luspatercept, at least some impact will be had on enrollment in the PIII MDS study. bp

Ah, that would explain Dr. Scarlett's careful parse about likely increased acceptance and usage in Europe because of the strictness required in following approval parameter wording there. bp

CKTC, Good point but since Lus has shown efficacy mainly in RS positive patients (15% or so of MDS), I am not sure docs will be attracted to use Lus in all comers for that reason and may be selective. Also, and I base this on intuition only (not always an accurate commodity), since Lus works "downst...

There has been a lot of discussion about the recent (surprise) ATM. Speculation has included raising funds for the long promised AML study, a de facto "poison pill" to prevent a hostile take over, acquisition of some synergistic company etc. But these are not normal times. My own opinion is pretty s...

CKTC and Bill, thank you for clarifying. The PDCO process seems to be a little more public than the actual approval process. For example, I don't think we knew that orphan designation was under discussion until the PR, I imagine the same would be true for MA, if it is even under any consideration at...

Incidence of MDS in pediatric age group: 1-4 per million. Population of Europe: 741 million. High end estimate of pediatric cases 4 x 741= 2,964. Low end estimate of cases 741. Orphan indeed. bp

rccola335, Thanks for posting this. What is curious to me is why and how the Pediatric committee is doing the reviewing when to my knowledge all of the hematologic studies have been done on patients over the age of 18. The only pediatric study I can remember was related to brain tumors and we know h...

Actually Robespierre on SA brought this one to our attention first. Thank you Robes! bp

Ryan, perhaps you are right. My primary goal here is to seek the truth where ever it may take us and to foster board discussion. As you know my favorite aphorism is "Surround yourself by those who seek the truth, and run like hell from those who have found it." Perhaps Bill has found it, I don't kno...