Avid Bioservices Inc (CDMO)

[jbainseky]

CP;

EXACLY my point. PPHM puts the package together with all the data, results etc. And yes, they COULD PR that, but I don't think they did that with Cotara did they? They simply said they were in talks with the FDA. Then they PR that there has been an agreement.

PPHM has stated they believe the trail is acceptable to be submitted with a registration package. They are not going to PR that they submitted one. We all know without the discrepancies, it was HIGHLY likely the FDA would have either provided AA and/or a phase 3. So WITH the discrepancies, the FDA will decide what the impact is of the discrepancies. Will they still get AA? Approval for Phase #? or will they say start over. That is the impact of the discrepancies.

Again, without the discrepancies we probably would not have received any PR prior to some result from the FDA and that hasn't changed with the discrepancies.

JBAIN