Imbark's schedule

[Fishermangents]

(repost from sdrawkcabeman, YMB 23 June 2016)

Primary completion is scheduled for Nov 2017. If primary endpoints are measured at week 24, that means the latest treatment would have to start in May 2017, and that's for the entire 200 pts. So you can see just how fast this trial is moving, and exactly why Imbark is in full enrollment prior to the internal review. If, instead, full enrollment was dependent on the internal review, as in the case of Imerge, then they'd have to rush to enroll some 160 pts between Jan and May to meet the primary completion date. This gives insight into the high expectations Janssen and Geron have for approval in Imbark; they've been enrolling the full 200 pts right from the start with full expectation of a favorable internal review being fait accompli. In other words, the whole trial design was predicated on the idea that a favorable internal review was just a technicality. I think that gives a real clear look into JNJ's and GERN's mindset, and what they're aiming for, which is an expedited approval in MF.

Also, something to consider about Imerge... you'll notice on the CT site it's listed as a P3, and also on the Mayo site. And we know once the internal review is complete, then the second part of the trial is classified as a P3. You realize what that means? The FDA essentially gave JNJ the power to decide whether or not to move to P3. That's a stark indication of support from the FDA, when the regulatory agency is willing to give the SPONSOR the full right to decide to move to a P3 w/out further regulatory input. It means they hammered out that agreement in discussions for the trial design. In fact, it sounds very much like a SPA. And regarding Imerge's primary completion date set set for June 2018, it means the study at that time will be the completion of a P3, not a P2. Both Imbark and Imerge are moving ahead very rapidly. Once again, with both internal reviews scheduled before the end of this year, we're going to see a flurry of activity.