"about Imetelstat"

[biopearl123]

I always find the "fine print" which we all tend to gloss over, interesting. Looking back, there were allusions almost a year ago in the "forward looking statements", hints that Scarlett might go it alone with suggestions that Janssen may or may not continue the partnership etc. We know this all too well. So read the forward looking statements carefully. In this last press release there is only passing mention of MF with a clear focus on MDS. This seems to be pattern and has suggested to me that despite clear OS advantages MF was put on the back burner until the third quarter when a "decision" re development might be forthcoming. Why the third quarter you might ask. And
M you have. And so has everyone. Perhaps it is because Scarlett wanted to wait for the FDA to give guidance re the protocol for the MDS study, perhaps waiting for proof of durability (it would be quite something if the 24 week TI rates continued to be durable and now could be evaluated after another 5 months post ASH (data cut off was end of Oct). This really might convince the FDA to allow for the sort of accelerated approval we have been hoping for and explain why JS is deferring the obvious course regarding MF. Of course this is conjecture but we see lots of evidence of preparation for marketing, production and further forth coming studies. Ties with BP are being cultivated. Parsing the recent "about Imetelstat" in the PR: (in parenthesis are my comments):

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. (True). Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis (Recovery of normal hematopoiesis had not been emphasized and implies normalization of bone marrow). Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 or High-risk myelofibrosis.(True). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.(True). So we have three absolutely true statements in the "about" section keeping company with one other but very important statement about disease modification and recovery of normal blood cell manufacturing function. If it is true, (guilt by association), along with the other statements which we know to be true, this new class of medicine should be readily approvable. We know there have been CRs and PRs in both MF (not R/R, but still improvements) and some MDS patients with major bone marrow improvements. So the iffy statement IS probably true for some patients even thought the forward looking statements won't allow that conclusion to be drawn with certainty. The question now is for how long--how durable are these remissions, and associated transfusion free intervals. Well we know that at least 5 more months of data should be before the FDA now.
Maybe, just maybe that's what all the fuss is about. bp

[huntingonthebluffs]

Excellent thoughts biopearl! I often think we spend too much time worrying and trying to solve the science questions around Imetelstat, combinations, etc which we cannot fully see or understand from this distance. While not spending enough time on what is actually happening at Geron and at large to continue the studies, expand the corporate ability to move this towards commercialization and reasonable interpretation of what JS/Geron/FDA are doing to make this all come to fruition. I will wake up on your points about reading the fine print, including the forward looking statements to help stay grounded here in light of the uncertainties as well as the seemingly illogical bashing on the other boards. Thanks again for your thoroughness and dedication to finding the truth.