Replies to post #183889 on Avid Bioservices Inc (CDMO)

[BioBS2012]

P3 Interim Look-in's.. There has been discussion that there will be two interim look-in's for the P3. Are these two look-in's event driven? Pre-Planned Scheduled Dates? or any two times that PPHM wants?

They would have to be pre-planned to carry any weight - meaning that it is something they included in the Phase III Protocol that was reviewed and given the go-ahead by the FDA. JMO

[dia76ca]

Here is what Shan said about the look-ins on the last CC.

"We remain on track to complete enrollment of approximately 600 patients by the end of 2015, with two planned event-driven interim data analyses."

[Protector]

That information has been disclosed. The loo-ins are event driven.

I think we will never get their (I mean to even the first look-in). I think we will be stat sig on N=100 (50 patients control arm, 50 Bavi arm) and that the trial will be stopped early by the Data Monitoring Committee when stat sig so the control arm patients can benefit from Bavi.

I take a very simple counting rule. I say patient number hundred enrolled JUN 2014+7.5 months.