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.