Avid Bioservices Inc (CDMO)

[nuke661]

Carboat,

I'll impose myself into this discussion if you don't mind; after all it is an OPEN message board. I was involved in this same line of discussion almost 2 months ago with exwannabe in post 112963. Ex never responded so I let it drop. But the issue keeps coming up.

First, I'll answer your question which was

How would you characterize it? Low number, typical, on the high side, very large number .... What?

My answer is "it is what it is and the numbers were generated using required FDA censoring methods by an independent medical review board and the resulting data for MOS is valid per FDA methodology". Please see my detailed position I provided in post 112963.

Now, would you please respond to/answer Mr. Bungler's request/question that he posed to you that you either forgot to answer or, maybe you thought wasn't a question or, maybe you thought you did answer. The request/question he asked of you was (see underlined words)

Your statement implies that there is some established or recognized standard regarding numbers of censored subjects in a clinical trial. If you have knowledge what this is please elaborate.

Do you have published information such as FDA guidance or reports or any industry reports that would show that the censoring numbers in the PPHM trial data is an aberration or represents data generated in some type of non-professional and/or deceitful manner?

If you don't have the ability to point to published information on this subject then respectfully I have to say your position that the PPHM 2nd line trial censoring numbers being out of bounds is without foundation and carries only the weight of opinion without any supporting logic or documentation.

I have tried to find an FDA document dedicated to the subject of censoring that would provide clear guidance on this matter but I have not been able to find one. I would welcome your help in finding such information. It is important to me and, I'm sure to all investors, to know just if the 2nd line NSCLC data - as it currently stands - represents data not meeting FDA expectations and guidance for NSCLC clinical trials.