Replies to post #184635 on Avid Bioservices Inc (CDMO)

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I don't recall PPHM stating they used an outside firm to conduct the P2 review:

While continuing to oversee these ongoing clinical trials, Peregrine is also conducting a detailed internal review into the discrepancies tied to the randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line NSCLC that were discovered as part of the routine collection of data in advance of the company's end-of-Phase II meeting with regulatory authorities. The goal of this review is to gain a thorough understanding of the events leading up to, including and following the patient treatment group assignments and investigational drug coding and distribution. This review includes the testing of investigational product, patient samples, reviewing the operations of multiple vendors, among other activities. Investors are reminded not to rely on clinical data that the company disclosed on or before September 7, 2012 regarding this trial.

today provided an update from its internal review of discrepancies from its Phase II randomized, double-blind placebo-controlled trial of bavituximab in second-line non-small cell lung cancer (NSCLC) in 121 patients. The review was prompted by the discovery of vial coding discrepancies while preparing for an end of Phase II meeting with the FDA. The internal review included a thorough operational review of multiple third-party vendor operations at sites worldwide, testing of investigational product used in the trial, additional patient sample testing to determine drug levels and a review of immunogenicity testing results from the trial.