Replies to post #94332 on Avid Bioservices Inc (CDMO)

[Bungler]

FTM, since as you pointed out the data has not been submitted to FDA, and the coding error discovered prior to FDA EOP2 meeting - why would it make any difference to the FDA whether the data that would be submitted for a Phase III approval (assuming the coding error is correctable and the analysis redone) first had to be corrected and confirmed internally and/or by another third party? Why would it make any difference to the FDA that the company publicly reported the data before discovering the error and then correcting it? It might matter to the SEC, but the FDA is prohibited from any consideration of financial information such as stock price gyrations. Therefore I do not see why, if the coding error is identifiable and correctable, that we would not still have valid Phase IIb data.