RE: Update on phase 3 trial22 Apr 2022 14:58
it's certainly difficult to remember all the details of each step over a long period,but if you recall the EU situation was different. fum were relying primarily on the med 3000 trial data,which was detailed in top line form to the market in dec 2019, to form the basis of their technical file for CE application. as such there wasn't really anything new to be disclosed. obviously with the FDA de novo application, new data is being generated and i am certain that will be disclosed to the market at the appropriate time after the trial completes, just as with a brand new trial, which is, of course, what it is.provided that is confirms the previous results, according to the criteria and parameters agreed with the the FDA,all should be fine.fingers crossed.