Replies to post #202377 on Avid Bioservices Inc (CDMO)

[biopharm]

BioBS2012,

that Opdivo trial was not double blinded.. right? N= 272 also... correct?

Now, that means they stopped it early and didn't even meet n=272 so it would be interesting to see how far off from that # they were and how that # compares to a double blind study such as "Sunrise".

Lots of questions I have but seems like I have to wait till ASCO

The thinking out of the box would be if the FDA ever approved Bavituximab for all FDA approved SOC, then BMS is ready to go with Opdivo+Bavituximab and they don't have far to go to beat SOC

[InternetForumUser]

BMS ENROLLMENT COMPLETED: ~November 26, 2013, So BMS took around 14 months to enroll 264 Patients at 106 sites.

So if PPHM P3 has been ongoing for about 12 months but with around 152 sites. So would one expect PPHM to have enrolled at least 264 Patients in that same time frame?

Is PPHM enrolling at a faster rate or slower rate? If the P3 kept to the exact same timeline as the BMS Trial.. then April 2016 would be the date; however, I doubt the timelines between the two trials would be so similar.

Estimated Enrollment: 264
Study Start Date: September 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

For Reference purpose, here are details for PPHM's SUNRISE Trial

Estimated Enrollment: 582
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)