Avid Bioservices Inc (CDMO)

[Explorergypsy1]

from yahoo
by Rogerabc
Questions & Answers on Peregrine Discrepancies

What is this all about
It is about Peregrine discovering major Discrepancies in unblinded clinical trial data which makes the previously announced results unreliable for investment decisions.

Who discovered this
Peregrine's team during review of the data that was unblinded in May 2012. It was not discovered by a potential partner as part of data review, nor by the CRO (Clinical Supplies Management Inc), nor by the FDA (that data was never presented to the FDA at that point).

What exactly was discovered
Major discrepancies in coding, not anything else such as wrong survival data, problems with censored patients, the use of a wrong substance, etc.

What coding then?
Coding in labeling of Treatment Groups, that is, which patients must receive what treatment. There are 3 arms to which a patients can be assigned, the control arm that receives SOC+placebo (SOC=docetaxel), the Bavi 1mg/Kg and 3mg/Kg arms that receive SOC+Bavi.

Is all lost?
No, on the contrary, all could even end up better. The randomized assignments of patients to the 3 control arms is not involved. That would have been a problem because if it was it would almost for sure invalidate the trial. The control arm is not affected either, which means that MOS of the control arm is and stays