I really do hope the p-values have been crushed, but we haven't heard even a suggestion of that from CytoDyn. And, frankly, efficacy has appeared to me as being handled in quite a defensive manner, to date. This is just my opinion, and I would be happy to be wrong, but Dr.NP would not have been able to stop himself if the numbers had truly been crushed, even if they were secondaries.Quote:We would not be submitting an application to the U.K. for approval in COVID-19, if the data was not going to have a significant impact...."crushing the P Value."
In my estimation, with sudden the loss of the small Mexico trial as leverage against the FDA, this UK / European PR seems designed to function as a Mexico proxy. In other words, it seems to be designed to motivate the FDA to resist their temptation to demand a larger Phase 3 Registrational.