Avid Bioservices Inc (CDMO)

[Protector]

For those still doubting the BLA possibility!

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

source: FDA

Meets the FDA requirements means: Safety, Efficacy and Production Process

PPHM has a boat load of data and TODAY has a complete dataset that, after salvaging, has an 113% statistical significant improvement of Doce+Bavi on Doce+Placebo, compared to the 60% non-statistical significant set that they used (combined arms) to apply for the SUNRISE PIII.

Additionally PPHM has 582 patients enrolled that were treated with Bavituximab that they can add to their safety database. Bavituximab under this total number of patients (more then 1000 in total) has never show ANY meaningful side effects of its own.

Additionally they have now a 177/2 (near 90) extra results on Doce+Bavituximab that they acquired completely according Double Blinded standard and which can validly be added to the Action Package.

And PPHM has several provisions allowing them to move to the FDA based on sub-groups (as per Shan).

Additionally PPHM has a Fast Track for the study that was granted on the data of the PII !!! (see also PPHM's PR about Fast Track).

The requirements are simple:

- BLA action letter
- BLA Action Package (with EVERTHING of this STUDY - not just SUNRISE PIII)
- Production Facility data (prior to an approval)

PPHM has EVERY SINGLE PEACE of that. So if they file the only question that remains is: What was the reason of the control arm dramatically out-performing and does it QUALIFY for the provisions in the protocol and are therefore the approval conditions acceptable for the FDA because the provisions apply. Last report Dr. Garnick was still investigating the control arm issue.