Replies to post #112851 on Avid Bioservices Inc (CDMO)

[EYEBUYSTOX]

Transparency has never been their strong suit. But it would be a crime to 2nd line NSCLC patients all over the world if they did not at least apply, knowing (as we all do) if it weren't for some clerical error, a statistically significant doubling of survival would have occurred. Again, in reading through the breakthrough designation application process it appears to be a very simple addendum to an existing IND that would already be on file at the FDA for the 2nd line NSCLC trial.

Breakthrough info:

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm

What is an IND:

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm071098.htm

Receipt of a non-designation letter would most likely never be disclosed by the company so there's almost no economic downside in applying, especially after enduring the exhaustive task of scrubbing the entire trial data to make sure their findings were correct.

An end of phase II meeting would still most likely occur and breakthrough designation would simply mean the company would have some extra attention from the FDA in defining the goals of a confirmatory trial.

I think it was filed (or re-filed) on or around Jan. 3rd followed quickly by the Jan 7 PR. It might explain why 60 million shares traded that day and only 6 million shares traded yesterday. Given that the FDA has 60 days to reply, PPHM then scheduled investor conferences 60 days out starting on March 4. Whatever the FDA replies, PPHM will know their investment needs and can proceed accordingly. Just a theory and all IMO but there's only 2 weeks until March 4 so we'll see.