Outside investigation is likely FDA investigating the CRO.. If PPHM management is correct and this is the fault of an independent contractor, then this is a CRO that has assumed sponsor responsibilities.
From the FDA:
"A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to "sponsor" in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor."
Perhaps PPHM can't comment publicly on the details of the discrepancy until the investigation has been completed.
Also, if investigational drug = investigational drug then
If Peregrine's definition of investigational drug in the PR is the same as the FDA's in the regulations stated on testing drugs in humans (which I assume it is as this could be used against them in lawsuit if term is used improperly), then this discrepancy should be limited to the treatment arms. Impact is that x number of pts will need to be censored, but MOS for bavi might still show advantage for pooled data.
From PR:
"A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product."
From the FDA (CFR 21 part 312 - laws governing IND applications to use product in human trials):
"Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous for purposes of this part."
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