Avid Bioservices Inc (CDMO)

[RRdog]

Thurly,

It is clear to me that the FDA and the law is getting more and more flexible in this area and survival is the key stat superceding the surrogate endpoints.

It is also clear to me that the FDA wants to maintain this new flexibility and wants the right to pull an AA drug if it doesn't further prove out.

That is the point I was getting at in previous posts. In order to maintain that flexibility the FDA wants assurances that a full phase III will be run in addition to the AA acceptance.

My point, and I know you agree, is that PPHM will need a major partner for Phase III and be ready to kick it off before AA will be granted.

I think partners will move on the data and will be fairly confident they can get an AA while they go forward with Phase III if the MOS is anywhere close to where I and others have been predicting it will fall out.

Best Regards,
RRdog