Replies to post #252599 on Avid Bioservices Inc (CDMO)

[exwannabe]

More on numbers:

Also, we know that 1st & 2nd look-in happens at 33 & 50 % of ??… NOT necessarily ??

This is simple. The trial is designed to enrol 582 patients, and the final analysis is planned at .8*582 = 466

The SAP that is part of the trial will state that 466 number. It has absolutely nothing to do with censors. It would remain 466 if the trial was to over-enrol (likely) of under-enrol (unlikely). Same if the drop out rate was high or low.

They state that number as "planned" because it is a real time process and they can not be exact about hitting the target and cutting the data exactly at 80%. Is is common for a few extra events to slip in (and sometimes the reverse when trials have softer endpoints).

The looks are at 33% and 50% of that 466.

Golfho:

That implies that there is, in my view a 28% probability that the trial could be stopped at the first look-in.

Nope.

The trial can not be stat sig at the first look as there is no alpha assigned (if we believe SK). So one can not possibly assign a percent chance of being stopped for such.

[sunstar]

Tradero, thanks. As SUNRISE finishes enrollment, Peregrine will certainly be leveraging their large network of clinics and hospitals to rapidly enroll new patients in the next round of trials, like the Bavituximab plus Durvalumab immunotherapy combination and HER2-negative metastatic breast cancer. Because the clinical centers are already fully engaged with Peregrine, these smaller open label trials should progress quickly and start providing new data for investigators.

The Bavi plus Durva lung cancer trial will exclude patients with:

“Prior therapy with a PD-1 or PD-L1 inhibitor, including durvalumab.” (which suggests how similar the PDs might be)

and,

“Prior therapy with bavituximab.”

https://clinicaltrials.gov/ct2/show/NCT02673814?term=bavituximab&rank=15

IMO

sunstar