We don't have all answers, but we have at least a dozen.....
ACTUALLY WE HAVE AT LEAST A DOZEN ANSWERS ALREADY IF YOU DO SOME DUE DILIGENCE....
1) We know the trial could have achieved approvable endpoints in Q4
2) We know a trial that only needs 3 months PFS was extended 3 months.
3) We know the control arm drug dox is actually in BOTH arms including Pali + dox.
4) We know the extension was not due to timing of patient enrollment as that did not change from the previous interim review by the independent DMC which said it could halt Q4
5) We know what dox can and can't do and if you do enough due diligence you can get a hint that the extension is not likely due to the control arm drug outperforming what it ever has done before.
6) We know based on a Journal of Clinical Oncology Canadian study that Dox does not work as well in patients over 60.
7) We know the median age of the IFOS trial that everyone is taking dox numbers from was 49.
8) We know that the Picasso 3 Palifosfamide trial has a good number of patients over 60, where dox (control arm) does not work as well.
9) We know that one thing Dr Lewis is is a brilliant oncologist.
10) We know the quality of this trials steering committee.
11) We know with IFOS many patients have to also take Mesna for side effects - with Pali you don't - so even similar efficacy with less drop outs and side effects would seem enough but it appears we have much more.
12) We know that the Picasso 3 trial COULD HAVE stopped for futility - but didn't despite multiple interim reviews by the independent data monitoring committee. We know there is efficacy. And we know the trial COULD NOT in its protocol stop for great efficacy until the predetermined number of progression events hit, which just happened.
IF I WAS SHORT I WOULD BE GETTING VERY NERVOUS ABOUT NOW. There is a huge percentage of float short and you gotta believe Kirk and Fidelity will move their shares to non-borrowable when data comes out - similar pattern in previous companies like clinical data and new river. I know a number of people who will be doing the same.