RE:RE:RE:RE:RBCI did not write that post to be negative on Prometic PDUFA date. It is just informative.
Also, it is important to note that these delay where probably expected like in Roche situation, they had submitted new data, so they probably new much longer before 8 days from the PDUFA that there would be a delay.
I am confident for april 14 as safety, efficacity, labelling are not an issu. Also, CMC (chemistry, Manufacturing and Controls) should be OK considering Laval plan was already FDA approuved and chemistry has also a long history of sucess as well.
And if ever there is a delay because the FDA is in reorganisation since uncle Donald came along, then so be it. But it will be approved, I have no doubt about it.