Replies to post #150450 on Avid Bioservices Inc (CDMO)

[jq1234]

Ex, no matter how hard you try, people aren't going to understand alpha spending rule, statistical penalty for early look of ph3 trial - they aren't interested in understanding the basic rules for clinical trial conduct and analysis, thus not going to listen to anyone who does understand the process. I am not talking about prediction of trial success or failure, just simple rules ph3 trials follow, otherwise they wouldn't have dreamt about all wild off base fantasy scenerios.

[Protector]

exwannebe, I tend to follow that reasoning.

As to "when" they look, it will be at some pre-defined number of events. They will NOT be looking at data real time to decide when to peek.

I think an number of patients (enrolled, treatments started and completed) has been set. The 5 week cycle or so. It will, and this is PURE SPECULATION, be 300 patients or less. More the 300 would not make much sense, if on 300 you have the confirmation of what your PII showed on 40 then you are good.

To few will also not float. The FDA, as well as PPHM, will want that interim sample statistically significat. So I think 200 (5 times the PII amount) is a minimum.

AGAIN: THIS IS SPECULATION!!! I have no hard data or prove that it will be between 200 and 300!