Thursday, July 07, 2016 10:36:20 AM
The few that are REALY unsatisfied based on time passing and delay of results would join in an opportunistic way (if they want to pay for a class action) and know deep inside that they have no real argument to go to war against management that can show a large number of achievements (salvage PII, building AVID, no going concern, collaborations with most prestigeous research centers in the world that are otherwise HARD to get in such as Memorial Sloan Kettering and NCCN, commercial collaborations such as AstraZeneca (and possible Merck if we know more from the new upcomming KeyTruda+Bavituximab clinical trial).
A management that has already suffered the ambulance chasing class action for FALSE allegation related to dissemination of PII results and won 4 times in a row up to the appeal court. A management that by the settlement of our CRO (CSM in Fargo) showed that PPHM was NOT responsible for the dose switching incident in the PII clinical trial, a management that by PACER can show they wanted to file for fraud and constructed fraud by the judge in a summary judgement said it was to late (it took time to investigate an be sure before making such allegations), a management that can show they ran a flaw-less PIII set-up and enrolment (only 6 weeks delay on planning and ALL patients needed by FDA enrolled within set timeline).
Furthermore management will have no problem to counter the MAIN arguments that will drive such a potential trial, namely SUNRISE.
They will show that:
- the executed and enrolled the trial according plan
- that bavituximab performed as expected by trial design
- that they anticipated Docetaxel to possibly perform BETTER then normally and as such UPed the expectations.
- that Docetaxel did not just perform better then normally but DRAMATICALLY OUTPERFORMED (the already UPed expectation as well as all historical performance data of comparable trials. In Opdivo it UNDER-PERFORMED by the way :)
- that they took PRO-ACTIVE action in SUNRISE protocol design with FDA agreement measures in case the SOC would change and/or a 3rd line treatment would become available during SUNRISE.
- that they took PRO-ACTIVE to deal with such situations as to the approval process by defining sub-groups in the design protocol with the FDA agreeing by approving the SUNRISE PIII clinical trial design.
I think that those that want to go at war against PPHM BoD/management, who saved PPHM after the sudden withdraw of the loan in 2012 due to the dose switching and panicking banker, will need good cards to plead 'diligence'.
An partnership/collaboration topics. Besides the fact that PPHM announces a couple of dozen (say 24 at least) collaborations of which we know less of 10, and in such trial - although they don't really need - could show the others, they can also prove they were close to signing a PARTNERSHIP with AbbVie (as mentioned on PACER) before the dose switching - sabotage - incident. And from the details that partnership was quite elaborated as it included helping PPHM with Sales and marketing matters etc.
And I am sure they will be able to show plenty of OTHER prove of partnership talks. A judge will NEVER hold it against them that no partnership came in existence because of the terms.
So maybe the thinking part of your phrase below should consider the arguments above and then make a counter list to see what such a lawsuit could do besides making the ambulance chaser grade firms that would be the only ones running such a poor case make rich. Ask north40K how these things go for shareholders if you don't have a real case, and sometimes even if you have one, he can tell you in full colour.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
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