Replies to post #310545 on Avid Bioservices Inc (CDMO)

[biopharm]

This is perfectly acceptable and FDA approved

All one must realize is Jeanette M Bleecker now known as Jeanette M Bona admitted in deposition hearings to swapping (sabotaging ) one of the combined trial arms yet why??

The final records were sealed from the public and CSM in Fargo ND agreed to have records sealed

The question we are left with is why did Jeanette swap those trial arms?? Given an incentive to do so ??

It is interesting that she HALTED her pharma career, never renewed her license and her boss CEO Gerald Finken of CSM was ex-Bristol Myers Squibb that stood to be the Big Pharma MOST TO GAIN as Opdivo was coming up for approval and if Jeanette did not swap the trial arms the FDA likely approves Peregrine's trial and becomes the new Standard of Care.

Sounds like someone had some explaining to do....wonder why CSM agreed to seal all records and they never wanted to pass over Jeanette's employment file ....

Lots of shady activity there it seems ....CEO Finken did lose that CEO title also so a downgrade? Hmmmm he is now a lab rat CSO as Steve King still remains CEO

How many filed for FOIA records to unseal those records ? There sits many answers

The answers do, fortunately.....are held in biomarker data and LOTS of biomarker data

[vinmantoo]

this looks bogus-

there were 3 arms and they're only reporting it as 2 and when the 1 mg/kg and 3 mg/kg are combined it looks better. what they're leaving out is 1 mg/kg out performed 3 mg/kg and the control out performed 3 mg/kg. Phony statistics make it look like bavi has some minimal positive effect but the truth is idoes nothing.

You hit the nail on the head! It is disingenuous to present the data for the phase II Bavi + Doc like that. Either don't mention it because it is completely irrelevant in light of the final Sunrise phase III data presentation to come, or give a more thorough explanation about dose switching and subsequent data massaging by adding arms together. You will note that even with the data massaging the P value is not significant at 0.11.