Avid Bioservices Inc (CDMO)

[nuke661]

Interesting stuff.

However, Masten encountered serious evidence of vial
mislabeling between the placebo and 1 mg/kg groups, use of labels that did not
comply with FDA regulations, and evidence of after the fact tampering (PSS 87-96),
indicating someone at CSM attempted to undo the "switch" ineffectively.

The patients in the study were late-stage lung cancer patients hopeful of experiencing an extension of life who were taking a chance on a drug that was being studied for extension of life. Bleecker also overlooked that an independent data monitoring committee reviews the data on such oncology trials, and could in the right circumstances recommend terminating the placebo treatments so all patients in the study could benefit and the study could refocus on the optimal treatment dosage.
Bleecker derailed that possibility for these patients. Her actions also undermined analysis of the optimum dosage size between the 1 mg/kg and 3 mg/kg doses.

Bleecker's misadventure in randomization undercut patient safety and delayed the availability of this treatment.

There is much more going on this case than unskilled workers labeling vials and shipping them to sites.

Peregrine had nothing to do with Bleecker's rogue conduct and had no knowledge of it.

Bleecker's rogue conduct went above and beyond
CSM's contractual duties as stated in the MSA, Work Orders, and PRS, and elevated CSM and Peregrine's relationship to a confidential and fiduciary relationship.

Peregrine was also on the cusp of partnering with a large global pharmaceutical company to fund a Phase III trial in NSCLC, seek and obtain FDA approval, leverage the global pharmaceutical company's commercial sales and marketing expertise, and to fund future advanced clinical trials in other indications.
D. CSM Botched The Job Bleecker transgressed many FDA regulations, including those contained in 21CFR Parts 211.125, 211.130, 211.142 and 211.150 and 312.52.