Replies to post #279970 on Avid Bioservices Inc (CDMO)

[corporalagarn]

"This is to be separated from what PPHM gets out of the trial, never the less, that will speed up things in future and work towards better clinical trial design (biomarker usage) and apart from the fact that Sunrise demonstrated again that bavituximab works (even though not approved for trial regulation reasons)."

Was this their goal going into the trial or was their goal to get FDA approval?

TRIAL FAILED!!!

[ku]

Tampa, there is nothing funny about that statement. When Dr. Garnick said that the data could not be used (because not obtained fully blinded as required by the FDA) for filing a BLA (70% improvement over SOC in statistical significant way) then the trial FAILED from its perspective of finding approval. That has NEVER EVER been under discussion since it was final. As long as it wasn't all doors were open.

So I guess our genius CONSULTANT garnick blew it