thanks R622! I should have remembered to read that complaint over again.... this story has too much info.
The interesting part would be if Abbott actually ever tried to reduce their original offer for the partnership signing after all hell broke loose. I do find it interesting that they are setting up for Phase III NSCLC.
Plaintiff Fahey made a FOIA demand upon the FDA to obtain the SOPs, the Clinical Protocol and the Case Report Forms on the Phase II Trial, but the FDA refused to produce them.
This request proves that the Class Action attempt has NOTHING to do with the claimed SEC infraction. It is not only held up to LINGER but apparently now also to try to force a way into data that will otherwise NEVER be disclosed to the public.
If you claim that 4 people (in this case PPHM's SK, Little, Shan and Garnick) knew before Sept 7th that the results that were going to be announced in Chicago were not OK, then you have no need to look into the details of the trial FROM Before the unblinding.
You want to know WHO, HOW and WHEN did someone discover the dose switching, when and how was it reported and to whom. And, from there, was this before Sept 7th or after and if before was the reporting at that point (without any verification) of such a nature that one would at least have had to stop the Sept 7th Chicago presentation pro-actively. A company cannot do such a thing lightly because for sure there will be often "said problems" which after verification are NOT.
For the CA claim to be valid:
A) PPHM had to know AFTER unblinding and BEFORE Sept 7th, because before the unblinding they were in the total dark. On MAY 21th PPHM PRed only Top Line data. That means the trials was unblinded BUT details where still to be analysed.
B) Jeff Masten went to CSM for investigation AFTER Sept 7th. So some party must prove that PPHM know before Sept 7th and that Masten was kept from investigating until 2 weeks later.
C) On and about Sept 20th PPHM knew (officially PRed) about the dose switching (13 days AFTER Sept 7th)
D) PPHM knew FROM THAT POINT ON that 119% improvement over SOC was after a sabotage in their DISADVANTAGE and so results would be better.
E) Hence, PPHM advised NOT to rely on the data for INVESTMENT!!! Normal, the results were better and there are not only LONGS but also SHORTS. So the DATA could NEVER be relied on for INVESTMENT.
BUT the ABOVE proves that under NO CIRCUMSTANCE PPHM allowed "overly optimistic" data to be announced on Sept 7th (PR or Chicago Conference) because EVEN IF THEY KNEW what was in point D above (and it cannot have been ANYTHING ELSE because we know today exactly that it was a 25% dose switching or Bavituximabs disadvantage) the information they had showed EXACTLY the OPPOSITE - namely that the results were BETTER than what was disclosed to the public. So for the PR nor for the Conference was it a problem to announce some SUPER GOOD (but not even as GOOD as in reality) results.
Actually, the facts prove there was nothing by PPHM to know in the direction that plaintiff in the CA claims.
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