Avid Bioservices Inc (CDMO)

[sulaco]

Garnick's (BLA) - Biologic License Application


from About.com/industry/Pharma:

While it has some similarities to a New Drug Application (NDA), a BLA has its own unique set of requirements.

A biologics license application contains details on the chemistry, pharmacology, source materials, manufacturing processes, labeling and medical affects of the biologic product as well as data from clinical studies. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Since they contain information from pre-clinical toxicology studies to phase 3 clinical trial data, a BLA application may run to thousands of pages long.

Note the importance in the application process for "source materials" and "manufacturing processes."

Can anyone say AVID ????

The toxicology studies are there in spades for Bavi, and guess what?

Its safety profile is UNQUESTIONED. (Biopharm has been hammering this point for months.)

Bottom line? We get a BLA license for Bavi, making it a cutting-edge biologic to fire up the immune system, potentiating other oncologic therapies, and then it's LIGHTS OUT.

Always remember that Bavi dovetails nicely with other chemotherapeutics. This is CRITICAL, as it doesn't threaten other regimens necessarily. It makes them BETTER.

This is the pathway to its success. Oncology likes innovation, but SLOWLY. Bavi is positioned perfectly.

http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/


GLTAL,

Joe