Avid Bioservices Inc (CDMO)

[nuke661]

PDB,

I'm not sure where you get your logic from. The medical review committee made the recommendation to combine the groups and they are, by the rules of the blinded trial, outside of Peregrines influence for this process. Again, no more than 25% of the control and 1 mg/kg arms were affected so the impact you are implying would require what I believe would be a significant set of low probability occurrences lining up just right to say the 1mg arm was actually worse than the control arm.

Your statement that the MOS of the control arm was better than 1mg arm has no supporting basis and is in fact not supported by the data that is publicly available.

The real impact was having to give up the 1 mg/kg arm altogether and losing any chance of statistical significance using the larger population the combined arms would provide.

Some people keep trying to imply that the censored patients were a ploy used by Peregrine to skew the data. I'm not saying you did this in your post but the subject matter you are discussing seems to always end up with that discussion occurring.

Show me a trial for an end stage disease like 2nd line Non-Squamous NSLC with a 120 people that doesn't have censored patients. The Bavi trial percentage was slightly higher than the few trials that I researched at the time (including Avastins PIII that had hundreds more patients) but nothing that would have caused me undue concern. AND, the more salient point is that the INDEPENDENT medical review committee makes all the decisions on censoring. So unless someone wants to create their own conspiracy theories for the doctor's in the medical review committee and Peregrine conspiring to skew the data by censoring patients then I believe there is no basis to imply the censoring was improper.

Your statement of

When they finally realized that B was not 1 mg/kg but control they panicked.

implies something that is not true. The arms were at most 25% cross contaminated and it is totally unknown to us how the individual affected patients' data affected the results.

As far as my read on the CSM summary judgement filing based on JB's statement, I'd be very surprised if it actually led to a judgement in CSM's favor. I'm not a lawyer and have no legal expertise but I've worked in a extremely regulated industry for my entire adult life. The work I do is subjected to constant adherence to regulatory controls. I deal in findings and reports from regulators and responses to them all the time. The CSM filing doesn't pass the smell test in the slightest. The only basis for JB's defense in the filing was her saying "well I emailed them, what more do you want me to do..." (of course I'm paraphrasing her declarations with my wording).

In the real world involving a significant issue in a regulated industry, the responses to regulatory authorities would have the entire regulatory and contractual structure spelled out as to what was required by law and what was required by contract (I would expect no less in legal proceedings). The response would then provide specific statements that they were adhering to the regulatory and contractual requirements. They would back all this up with QA programs, approved procedures and work performed to those procedures via paperwork that was reviewed and approved by multiple people, not just one worker saying "I emailed them...".

If there was in fact such an issue occurring where there was a breaking of the blinding then I am absolutely confident that regulatory requirements and procedural processes would have required that this be documented in official correspondence between PPHM and CSM and required to be signed by officers of CSM.

The use of an email chain that is extracted out of context from the entire communications chain of events associated with the formation of the trial contracts and the final agreed upon procedures, along with the lack of any other proof of official communications and documented procedure records and no specific quotations from regulatory and contract documents, just plain smells as a weak shot in the dark effort to have the case dismissed. Of course this all just an opinion. The real result will be what the judge says.