Replies to post #260965 on Avid Bioservices Inc (CDMO)

[Protector]

jbainseky, two things.

A) I only said I am guessing about HOW MUCH the added margin was for the CONTROL arm expectations.

B) I did NOT expect Bavi to outperform PII results in SUNRISE PIII. Not sure how you came to that conclusions.

I think it is fair to say that after the salvaging the Sept 7th 2012 results (113% outperforming Docetaxel alone) is what PPHM knows Bavituximab can do, no matter whether they filed the conservative (their own words) 60% improvement to the FDA. Brekken confirmed at NYAS that the results of the PII were BETTER then what was filed. Officially at that point 60% is what the FDA goes on.

In PII the MOS of the CTRL arm was 5.6 but sicker patients. In PIII the studies with healthier patients give an historical approx. 10 months.

The PII was DOSE SWITCHED in the disadvantage of Bavituximab but I didn't even consider that as a possible reason why Bavi could indeed outperform PII in PIII. Furthermore the highest % ECOG 2 patients was in the BAVI 3mg/Kg arm in the PII, another thing that was against Bavi in the PII and that I did not consider as a reason for the PIII doing better then the PII.

CTRL: 5.6 vs 10 mounts (RECENT studies PPHM speaks about).
BAVI: 12 vs either 10+2=12 (no margin), 12+2=14 (my GUESS margin of 10+2 for CTRL arm)

AND ... 12+4.4=16.4 bavi potential if Doce on healthier patiences would account for the difference between 5.6 and 10 in the PII/PIII control arms, and hence also in their Bavi arms.

So it is my guess that the CTRL arm may have performed ABOVE the expectations for the Bavi arm, there is no other explanation that I can see. And that can NOT be explained with a DOSE SWITCHING because that would have been Bavi against Bavi. So 3rd ln treatment for control arm patients that saw progression is the only explanation remaining IMO that explains the dramatic CTRL arm outperforming.