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biopearl
Posts: 367
Joined: Wed Dec 09, 2015 12:12 am

Welcome to Q2

Post by biopearl » Mon Apr 02, 2018 3:03 am

Hello and best wishes for a Happy Passover/Easter season to all. We are now entering Q2. The importance of this quarter and the next need no emphasis but I will summarize what we know will and what I think might happen. We know that the next internal review will occur "before the end" of this quarter. Since January review resulted in a public announcement on March 15th, it seems reasonable that the results of the next internal review will be announced around about two and a half months or less after completion of this next review. Since the clinical trials site called for the study to originally stop on May 4th lets for the sake of argument say the study stops at the end of May (not including the extension portion) so results might reasonably be shared with us (and the FDA) by mid August, two and a half months later (if they are not all on vacation). If the FDA takes 60 days to review the data (it could be longer, but come on already!), then some change in drug status could be announced by mid October. Some will think this too optimistic but that's my timeline. Best available therapy (BAT) is possible but more likely is AA (accelerated approval) possibly with a mandated ongoing phase III after conditional approval. Or we could find ourselves facing a plain vanilla PIII, but perhaps in expanded front line indications. Based on previous posts by myself and others a possible scenario is that the 4.7 group reaches MOS but the 9.7 group does not. That's where I am betting. Before mid August comes the annual stockholders meeting in May. Usually some tidbit is saved for that so there could be the release of some positive info. Once Q3 starts we can anticipate the continuation decision (which I officially rename the acquisition decision). By early December ASH we will know a lot including the decision to go ahead with AML studies (my opinion only). If the data is as good as we hope ASH will be abuzz with presentations. There is much to look forward to and so far no red flags for which we are all watching carefully. In MDS if the additional 20 patients confirm the amazing data presented at ASH then part two of that study will proceed. By the way much as I try to stay away from short seller and market manipulators, if you haven't visited the YMB lately it is awash with attempts to sow FUD, I recommended it for education and entertainment only. Best Wishes, bp

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