Request fo additional information14 Nov 2025 07:43
So the submission was on 11th August. 90 days would have brought us to a decision point of around this week (when we got the notification that more info was required).
It just so happens that 2 weeks ago (28th October) we got the notification for the open offer. I don't know for sure but going on past form I'm going to assume that's when they really got the request for more info. It would also mean that the worst case scenario is that we still have 2 weeks on the clock (I think Soupdragon said the clock stops when the request is issued and starts again when the resonse is received)
They've said that the request is the same as one they received from the EMA and they will respond with the same data. That should be straight forward and should be something they could organise within a few days. Lets say they hadn't done it before they notified us on Tuesday. They should be able to do it by the end of today or at latest middle of next week? It is critically important, after all.
That means, if clock stopped 2 weeks ago, then it should start ticking again at least by next wednesday. Although if they only received the notification this week then there should be no time left on that clock and it should get processed immediately.
We should have FDA news in 2 to 3 weeks max, if it's not just more BS.