Avid Bioservices Inc (CDMO)

[biopharm]

good points CP and now since all should realize that Peregrine Pharmaceuticals has full access to the data now, vs 10 months from now as was formerly expected (10 months time in the race for a cure or race to IO combo is a long time!).... this brings up more than one possibility.

I'll skip to the highlight, where Garnick MUST be busy in verifying the "going as expected" Bavi+Docetaxel arm and this will be pretty amazing that they have hundreds of more patient data for their BLA filing, because when I read this it says that a phase can be skipped and they give as an example Phase I and skipping directly to phase III.

No where does it say that Peregrine would be unable to use their "going as expected" Bavituximab arm towards filling up some electronic BLA filings because that BLA package could be quite valuable. Garnick has already 1.5 years ago had the BLA filing up to 100,000 pages and there just may be a goal on net here when no one expects it, especially with the addition of an FDA voucher that would expedite matters in a method where AstraZeneca+Peregrine could win this race. I am sure Garnick has something else for this very last speed bump on this road we have all traveled.

New Drug Application (NDA)/ Biologics License Application (BLA)

If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.

At the time of application Priority Review can be granted to drugs that treat an unmet medical need.

http://www.fiercebiotech.com/topics/fda_approval_process.asp