Avid Bioservices Inc (CDMO)

[Protector]

nuke, because otherwise it is not a golden standard trial. It would allow the manufacturers to manipulate or invalidate the trial, willingly or unwillingly for the worse or the better. This goes for all manufacturers Bavi, placebo and SOC. The testing must exclude that.

See also FDA guide for clinical trials and Peregrine lawsuit filing. Peregrine signed an MSA with CSM, which automatically includes CSM must adhere to the FDA regulations. See 8, 9, 12 and 13.
You can use my Analyse post as a short cut to the full text link.

See also Merix case filing. Merix expected these test, even in a lower grade of clinical trial, because they thought they where under a CDA with CSM (while technically they were not as far as the court ruled). The result was that wrong manufacturing shipments where not detected with all consequences related to it for Merix as they have no valid work order. They didn't need a higher type of agreement (MSA) because it wasn't a double blinded test.

Quick quote for those that don't want to look it all up:

...Peregrine had entered into a written Master Services Agreement ("MSA") with Defendant CSM in March 2010. Pursuant to the MSA, the parties executed a Work Order which became part of the Agreement.
...CSM was hired under the MSA and its Work Order to perform the "double-blind" study and competently carry out the study to conclusion.

The mentioned work order MUST (mandatory, otherwise the FDA doesn't recognize the trial) conform with the trial design guidelines, in this case of those applicable to the double blinded placebo controlled etc trial type. So there is no doubt that Peregrine had this type of work order (because it is stated explicitly, including signing date).