Avid Bioservices Inc (CDMO)

[purpledawgs]

Thurly - check out the slide on page 48 of the pdf (page 49 down in the corner).

http://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm103366.pdf

"Statistical / Clinical Significance ?
•Best case –have both
•Can you have stat sig. but not clinical -yes
–Approval likely ? No
•Can you have clinical sig. but not stat -yes
–Approval likely ? It depends
•Phase 2 results
•Statistical design may become inappropriate
•Safety advantage, Other
•Clinical benefit is the goal!"

Sounds like bavi to me!

IMO

pd