Replies to post #260826 on Avid Bioservices Inc (CDMO)

[jbainseky]

I don't believe "toward the upper end" EQUALS "max from Studies at that point"

FFTT

T

[bidrite]

SUNRISE satisfies all the conditions to file for BLA:

Whew, what a relief! For a minute there I thought we had stopped all chemo and was starting over from scratch to focus on I/O. I wonder if King & CO knows they can still get FDA approval w/ Sunrise trial? They must not, else could have told us by now. Perhaps we should send a note to IR and let them know to hurry and submit their BLA.

[jq1234]

>> Add to that that in a next CC PPHM has said they included some MARGIN in the CTRL arm expectations. So assuming 1.6 months (that would be a 6 week margin) the expectations for the control arm Docetaxel alone would be 12 months. And as CEO King says above, SUNRISE was designed for bavituximab to show STATISTICAL DIFFERENCE at 2 months (that means not only a difference - improvement - by two months but also in a statistical significant way) 12+2=14 months.


Kept repeating it doesn't make it fact, rather just showed either no biostatistics knowledge or intended to deceive. If PPHM used the assumption of docetaxel mOS 12 months vs bavituximab plus docetaxel 14 months, implied HR=0.86 (14% risk reduction), SUNRISE would need well over 1,000 patients, not 582 patients to achieve 90% power. For reference, the SNY/REGN failed 2nd line NSCLC trial with mOS=10.4 months for docetaxel arm you referenced, assumed 22% risk reduction (HR=0.78) with 90% power, enrolled just over 900 patients. Had PPHM assumed 12 vs 14 months, still decided to enroll 582 patients, they would have been MUCH worse than I thought. FDA certainly wouldn't approve a ph3 protocol like that.

Btw, try to find a simple online sample size calculator, plug wild assumptions you made to see if they make any sense.