>ABPI / BVTI – The problem I see with the data released to date is that there's no data on the ITT analysis, measured from randomization. My supposition is that the company missed on stat sig for that population (.06?) but managed .047 when measuring from vaccination…<
That’s consistent with (but somewhat different from) my comments on this subject in #msg-28607365.
In any case, the series of PR’s on the BiovaxID trial reminds me of INGN, and that can’t be good.
But if I'm understanding right, the randomization only takes place when vaccination occurs. The goal is can they extend remission. So going back the 6 months isn't an ITT since no one had been treated.
My guess is yesterdays release was mainly intended to get a preliminary data out and try to pursue a deal rather than wait until final data a few months from now. No deal would be a bad sign. Takeda and pfe have been really active in cancer vaccine deals.
I'm not advocating, maybe the company is a bunch of nut jobs and a 10 year trial is bound to be messy. Panel meeting should be interesting when everything is out there.