Replies to post #105113 on Avid Bioservices Inc (CDMO)

[exwannabe]

The trial wasn't flawed. There where discrepancies detected in the results of the data (results=processing the raw data into synthesized numbers) that could be indications for errors made by the FDA licensed 3rd party CRO that carried out the trial.

Examples of the errors that could have been made are:
- symmetric mixup, 3mg arm got 1mg Bavi and 1mg arm got 3mg Bavi
- non symmetric mix-up placebo arm got Bavi or Bavi arm got placebo.
- administration error, 1mg Bavi is administered and 3mg Bavi is recorded.

Only the LAST example is one that would only influence the conclusions but where every patients got we he/she needed to get. Easier to correct. The first two samples need more work to correct. In all cases the results after correction can be different for the better or the worse.

Not flawed? That is a joke. Giving the wrong treatments out is about as big of a flaw as can be imagined. Who's fault it is matters for naught, PPHM as "captain" takes the blaim.

As to your "administrative error", that is nonsense. They do not "record" who received what dose, they do not even know that. The grouping of patients into arms is handled by taking the locked dataset and looking into the "sealed" patient randomization database to match them up. If that process had been screwed up, it would be a minor issue as the dataset was valid. They would just reanalyse the valid data. Would have been done a long time ago.

As to the dosing errors, they be anywhere from a modest flaw (if a very small number of patients were effected), to a complete washout. Do not forget that each patient had multiple treatments. It is quite possible that many patients ended up with "mixed" treatments.

[The Other Guy]

Consider this as summary of events:

NSCLC Phase II trial data was successfully reconfigured and the results judged to be better than originally released. Management then went back to the nearly-locked-in-partner with the results and opted to use the added leverage to negotiate a more beneficial contract, or, better yet, opened it back up to all contestants. Meanwhile, management recognized the timeline to start the bid process from the very beginning and opted to do an ATM to keep the company cash-flow positive. While we complain about the amount of dilution it is causing, the dollar amount was deliberate because Peregrine decides to work with the FDA in parallel while partnership negotiations take place - knowing this could take significant time and resources (thus the new hiring). Management deems the leverage to be even greater if FDA is on the cusp of approving Phase III. The partner-to-be was also interested in partnering for Cotara and meanwhile Cotara gets approved for PIII. Management has opted to keep the Cotara partnership open as further leverage in case the nearly-locked-in-partner ends up the highest bidder - thus the need for the ATM. SK pays back the loan "early" and the default amount knowing the responsible third party vendor will compensate for lost damages.

[dawginlife]

when i said flawed, i meant it was not a clean trial since errors were made.

i did not mean it was not salvageable. A big reason i have accumulated a very big position in pphm, besides my strong belief in bavi's efficacy and safety, is that i equally believe the trial will be salvaged and presented to the fda to support moving into phase III.

hearing the company say as much only reaffirms my original thinking that the flawed trial will be salvaged and used as originally intended.

cheers