We would not be submitting an application to the U
Post# of 148183
Quote: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.
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.