Avid Bioservices Inc (CDMO)

[nuke661]

BioBS2012,

Regarding item 1 of your post; it is clearly the intent of a phase 2 to prove some amount of efficacy to support going to phase 3 trials. The following link is to a presentation on the design of clinical trials given by a professor from the Medical College of Wisconsin and it clearly lays out the purposes of the different phases of clinical trials.

Designing Clinical Trials

The purpose of PII to show some proof of efficacy is clearly shown at about the 9:57 mark in the presentation.

Therefore, all the noise regarding that the FDA only allowed Bavi to proceed to Phase 3 because it is safe is just wrong.

This presentation makes it clear - to me - that performing a double blinded placebo controlled vs standard of care trial in Phase 2 with a patient size of 80 in treatment group (size of our combined treatment groups if not hosed by the dirty deedsters in Fargo (Dirty Deeds - don't click this link if you are adverse to AC/DC )) stood a high probability of leading to AA with the data that was developing. It is also clear to me that Bavi more than met the standard criteria to move to Phase 3, The FDA didn't just allow
progression to Phase 3 because it was only a placebo and safe and therefore didn't represent any fallout risk to the FDA. That type of talk is pure ignorance of purposeful fabrication.