Avid Bioservices Inc (CDMO)

[skweze]

The First Amended Complaint filed on March 28 alleges with specificity that the switching was deliberate (compared to the more general allegation of "errors" in the original complaint):

17. On April 15, 2010, CSM's Project Manager confirmed again to Perceptive and to Plaintiff that CSM was following Perceptive's instructions and Clinphone Protocol. However, CSM's Project Manager's confirmation was false because CSM already had secretly and unilaterally swapped the A and B arms so that those patients that were randomized to the A arm (control arm) and supposed to receive placebo treatments, were actually receiving 1 mg/kg bavituximab treatments and vice-versa.

18. Peregrine's investigation in Fall 2012, revealed that CSM committed other labeling and distribution errors affecting the A and B arms above and beyond the swap of the A and B arms noted above. Further, CSM did not inform any other clinical vendor and did not disclose that CSM had made any sort of Clinphone Protocol change at all. CSM's Project Manager did not even advise CSM's own Director of QA that CSM had changed the Clinphone Protocol.

It will be revealing to see CSM's answer to this complaint, which should be due 21 days after service. (Unless they are given an extension.)

Switching the complete arms must be MORE then just a database thing. Here is why...