about the shareholders meeting

[Fishermangents]

Repost from Sdrawkcabeman (YHMB):

It was everything we already knew to date, though there was an emphasis on some points thanks to some direct shareholder questions. The Imerge P3 will start in Q4, but the decision to do so will be made in the summer, and the P2 data will almost certainly be presented at ASH. This coordination between P3/ASH bodes very well. The corollary is that we will once again be in the dark, since the FDA is going to see the top secret P2 data, as well as the ASH embargo. Procedure, good science, the competition, etc, but it sure doesn't diminish the frustration. It was good to hear Dr. S give concrete numbers to the question about the populations of MF/MDS, which should give perspective on the reality of this business, re the continuation decision. More on this later.

Dr. S stressed the potential OS and clinical benefit in Imbark, he did so at the Apr review as well. However, in Apr I wasn't sure how to interpret the dichotomy of expressing a potential OS benefit, and yet not resuming enrollment. I know they said the pt pop was sufficient to make that determination, but if there was clinical/OS benefit then why not enroll more pts who are deathly ill, both for the pts' sake and stronger data? I see two divergent interpretations: in Apr, my interpretation was that they lacked confidence in the Imbark data, which was sufficient to draw conclusions about the R/R pop, and thus close enrollment and cap expenditures. That's what initially led me to think we should expect a frontline MF and the close of Imbark. But after Dr. S's comments yesterday, I now see a second and equally valid interpretation, which is that the data was actually quite strong, and therefore sufficient, and therefore the enrollment was closed to expedite the trial; enrollment is quite a lengthy process in any trial, and the more patients you have, the more expensive and longer the process is. So, in fact, if the data was strong enough, then their intent on closing enrollment would be quite sensible.

What brought me closer to the second, more favorable interpretation is what Dr. S said about there being no specific threshold for registration in the R/R pop, and how, b/c of that, Janssen would have to make a value-judgement to justify a P3 based on "meaningful clinical activity," of which, of course, OS is king. And he elaborated on the significance and rationale of a R/R trial again, which is crucial to understanding Imbark's impact, even if R/R responses are less salient than untreated pts. Despite not being able to gives specifics, his guidance, that the best available info to us is Imbark's continued progress, gives me more perspective into the quality of the signal they must have witnessed; if he's saying the trial is progressing positively, then it can only be in the context that the signal is real, and then the corollary must also be true that they closed enrollment b/c they could move forward faster on a decision for a P3. Otherwise, what's the rationale to close enrollment if the signal is real?

And again, he discusses the decisions of trials to be made based on the totality of the Imet program, including Imbark, Imerge, and the previous trials, and also including the treatment landscape, as well as treating multiple heme malignancies. That sounds very comprehensive to me, it sounds like what you prepare for a late-stage candidate, for a very mature program whose data spans quite a spectrum. And so we have to put all this in the context that JNJ is a for-profit company, as is GERN. MDS represents a significantly larger patient population than MF. The license agreement pegs the continuation decision to the primary analysis of Imbark, and that might very well be the way this unfolds, but I don't think we can or should shut the door on the idea of Imerge becoming the leading indication (which Biopearl first suggested) b/c of the sheer force of ROI and the patent clock.

Some odds and ends. I laughed out loud at the woman's statement about not wanting go through another start-up. And that does put a point on all this. I remember saying a while ago that what Geron seems to be looking for, ironically, is another Imetelstat. To this issue, Dr. S spoke of other business actions, ie, mergers, inter alia... or, acquisitions, but that doesn't necessarily have to be an acquisition BY Geron. Also, I continue to struggle to understand why Irish's husband was asked to leave the trial, considering they're seeing a potential OS benefit in Imbark, how could it detract by keeping John in the pilot? It is certainly a development in the pilot if they're shifting pts in or out. Looking at the summation of all these developments to date, I continue to have the utmost confidence in Imet, Geron, and Janssen, but the journey has been longer than I expected. I suppose it is what it is, and I'll take it one day at a time, each day the closer to where Imet belongs, on a list of approved drugs for the spectrum of blood cancers.