Avid Bioservices Inc (CDMO)

[nuke661]

FTM,

Here is an excerpt from the NJDenny provided link

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2191&EncHid=&userName=bavituximab

that you currently are having trouble with:

human anti-chimeric antibodies
[HACA]:
HACA samples are collected at screening, Cycle 3
Day 1, Cycle 5 Day 1 and at Study Exit. HACA
analysis will be performed at the end of the study
and reported with the final clinical study report.

I believe this information may explain why PPHM had no ability to evaluate or detect the issue until now. Were these possibly the samples that were being discussed in the PR? Could they have been detecting high levels of human anti-chimeric antibodies in the control group where none were expected?

It also seems to imply that they were working on the Final study report; which seems to imply either MOS was reached in the treatment arms or they were going to issue a final report without waiting for MOS trigger in treatment arms. Your, thoughts on this will be much appreciated.