Avid Bioservices Inc (CDMO)

[Protector]

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 what 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.


There are multiple solutions to solve this.
- the problem did only occur for SOME patients, so they could be excluded from the results.

OR

- the data can be corrected if the means to do so are available.

OR

- the trial is lost because the damage is so extensive and cannot be correct so that it would be impossible, unprofessional, to present it to the FDA during an end PII meeting.


In this case, from all observations, annual, quarterlies, PR, FDA website updates, etc we know that the data will be presented to the FDA. We also know that Peregrine reviews the complete clinical trial, from before it was handed over to the CRO until it was unblinded and results processed.


Those two arguments point to solution 2, the salvaging withing acceptable FDA boundaries of the trial. Furthermore the time needed for this investigation also point in that direction because if the data would not be salvageable they would have known that based on the type of error and available means to correct it. In that case Steven King would never have said they where checking all the samples, the samples ARE those means. Checking all the samples is an activity you only do to save the trial no to assess the type of error and its salvagebility.

Last but not least Peregrine hasn't served CSM yet (maybe an update is possible, Bungler, North ?) which points to a possible settlement. Although not impossible, I don't think that if the clinical trial must be done all over Peregrine has the luxury to go for a settlement.

Maybe the strongest argument of all is that Peregrine has set a dead-line of Feb 15 for the results announcements. Setting such date requires a road map, why wait if you know the data is bad and not salvageable.