Replies to post #249544 on Avid Bioservices Inc (CDMO)

[jimsgtx]

New Drug Application (NDA)/ Biologics License Application (BLA)

If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug.

I think he may have said 50,000 pages.

[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.