Anavex Life Sciences Corp (AVXL)

[nidan7500]

Hi Boopka, great question. BTW, this is done all the time within FDA licensed sites. It is complex but it works b/c for the most part it is based on common sense.

See: Retrospective validation for application of batch/trial history and performance to trails , etc. not code for , "Boil the Ocean", but it's close.

https://pharmaguddu.com/process-validation-pharmaceutical/

Boopka:

How would the regulatory bodies interpret OLE data that clearly demonstrates continued and, perhaps, steady improvement over time? Trends, could be very important to demonstrate that while overall data suggests one level of improvement, the longer one is on 2-73 the better one gets.

It is a matter of summarizing the requirements (create a retrospective validation protocol. State clearly and comprehensively what you want-expect to prove. Develop and apply a detailed trial protocol (w/FDA reviews). once approved to execute protocols then very carefully evaluate the data, be certain that all measurement systems are validated and calibrated/controlled as required. There can be no device, even S/W used in the validation which has not itself been properly validated/inspected for its intended purpose/use.

You have a story to tell. Tell it. Use all supporting facts and process disciplines. Note: if the trials and data gathering were done properly and controlled then this is then a matter of getting all the facts in one pile. I have done this, it is not a trivial task but should be doable.