Replies to post #139769 on Avid Bioservices Inc (CDMO)

[cheynew]

I didn't see anywhere in the call transcript that Shan said "confirmation trial". Can you point to where this was said? Thanks.

[Thurly]

Quick reply CP,

We disagree on how the FDA views the data. They aren't persuaded that there has been any compelling evidence of efficacy—no strong signals, not even close to stat. sig. since Fargo blew stat. sig out of the water.

What they have seen is that the safety data is good so far. Given that, they are allowing the PIII.

Does Bavi work? TBD. We'd all like to believe it does.

You should be careful about reading the tea leaves. You may have sufficient reason to believe your conclusions but do the conclusions follow necessarily. There's a big difference and the number of alternative possible reads of the same evidence are legion.

We should get together some time. I read your neck of the woods has one of the highest "happy population" quotients in the world. I'd love to come see why . . . !

[geocappy1]

CP

I am starting to think the reason for not discussing is that it is an either one or other. IMO at the EO2M it was suggested we apply for some type of early approval. Either we get the approval with a 600 patient confirmatory trial OR we get a 600 patient trial with a early lookin for possible approval OR both.

I am thinking they were hoping to get a response from FDA before going public with either. Maybe they thought they had to give us something yesterday so they gave us the confirmatory (maybe not a slip) and vague early lookin.