Avid Bioservices Inc (CDMO)

[Protector]

CFH, yes 500K pages (electronically). They must include all relevant pre-clinical, PI, PII, etc data and the complete basis of their conclusions.

If there ever is a dispute the underlying data is with the FDA and can be revisited. They also may already do all the SUNRISE part related to treatment centres, the 3rd parties working on the trial,etc.

When they unblind the only thing that remains is SUNRISE unblinded raw data (a lot but quite easy and straight forward) and then of course processing the data (how many men, women, age ranges, blonds-brunettes :), etc, etc) and make the total and sub-group totals of both arms showing that the end-points have been reached.

Finally a graph will come out that will show the separation and it will have a p-value calculated and associated with the scalar results to show if they are statistically significant or not.