very positive27 Nov 2021 18:30
interesting and very positive posts this afternoon.for once i'm grateful to booth for highlighting the very positive nature of the fda trial contruct. i totally understand and accept the desirability of extending the inclusion criteria .this will (assuming a reasonably positive outcome), greatly strengthen the robustness to the trial data. i expect, in that event, fum will have no difficulty in maintaining a clinically proven statement despite the lack of a placebo comparator. furthermore, the fact that fum have been happy to accept what may be more rigorous trial criteria, strongly suggests significant confidence in the outcome,.bear in mind fum did not have to agree to an fda trial at all.they could have rested on their laurels and marketed in eu on basis of ce mark and gone for other areas without fda. clearly they are confident of the outcome and i am very encouraged by this. i think we should all be very grateful to booth for drawing this positive aspect to out attention.