ImetelChat

Clinical trials site for MDS study has been updated. Looks like that study will start to reenroll. Watching for MF CT site update for some guidance. bp

Looks like preparation for Phase 3.

Interesting post:

Repost from YMB
Sdrawkcabeman

Although Imerge's P3 was always designed as a double-blind, yesterday's update now indicates: "masked role: participant, investigator." It's either a detail they're just now getting around to updating, or they're putting a polish on it in prep for the P3; considering the timing, I think it too much a coincidence to be merely a perfunctory update. The significance is that a double-blind, placebo trial is de rigueur for pivotals. If the P3 is pivotal, then we can expect a speedy approval b/c they've been enrolling continuously, and b/c the prim/sec measures are short term, ie: transfusion independence of 8 weeks, albeit over the 2 yr duration. However, if the P3 is anything like the pilot and P2, time to response is relatively short, and they can hasten the NDA by opting for a rolling submission.

It could be that MDS will be approved first, w/an Imbark reboot for pts unexposed to JAK inhibitors, concurrent w/an AML trial. Consider how fortunate we are that a single drug, Imet, has three(and likely more) shots at approval, and very good shots, at that; it's a great boon to Imet that these heme malignancies are related. If it had been a one-off indication, the outcome of a single trial, like Imbark, would put a much harder edge on the outcome. The much-anticipated AML trial could conceivably be a very expansive P2 w/multiple combo agents. I think it likely that the trial design should, for efficiency and expediency, explore multiple combos. It'd have to be a much larger trial, w/several hundred pts; enrolling them into one overarching, coordinated trial would be more advantageous than running multiple independent trials.