Replies to post #95883 on Avid Bioservices Inc (CDMO)

[cheynew]

Wouldn't Garnick have been responsible for seeing this was done?

[jakedogman1]

sometime ago on the SI board, a former employee talked about all the consultants hired as "employees" where they were absent most of the time. could be part of the problem. also with so much turnover and disgruntled employees, would not be surprised with a "this one's for you stevo, good luck in two years cleaning this mess up." btw, the former employee did not have good things to say about stevo or pl for that matter.

[keep_trying]

Thurly, in a double blind placebo study, it doesn't make sense for anyone (including an ex Genentech employee) to claim that PPHM was remiss by not having someone on staff or contracted to review statistical integrity by auditing the blinding third parties while in the blinded period. Why? That "check" mechanism could be opportunitized to give PPHM trial result progress specific to patient dosing statistical information that could be communicated in a manner compromising the blinding. If your contact is saying other "smart" Pharma are doing such contracting to hedge their blinded trial risk, it begs the question as to what information they are receiving that hedges the downside risk of following study protocol per the FDA "Gold Standard" criteria. Even having another third party situated to review real time details of what the CRO third party contractor did or didnt do compromises the blinding if there is any actionable feedback to any party involved with the trial.

Perhaps, I am missing something here?

Best wishes and IMO.

KT

[EYEBUYSTOX]

Thurly,

The BV poster, Masterlongevity, posted that having a separate unblinded consultant for verification purposes was standard procedure in double blinded trials. However, Garnick was the regulatory architect for PPHM in the 2nd line trial and is probably as well-versed in clinical trial design as most BV posters. Do you find it curious that Garnick wouldn't put such a "basic" safeguard in place?