FDA decision timeline for phase 3 trials, page-6

Yep totally agree, strictly it is 3 months but they can extend easily enough. IF they need more time than 3 m they will respond with "We need more time".

Then it may go into some sorta holding pattern till they are ready.

We have submitted a lot of data, good data and had meetings with them.

But this is the FDA...if they want something more, they want something more.

We just need to see what it is. Once they have had a really good look through that data...they are gunna realise how widespread the application of this drug could potentially be, how deep the uptake might be at some future point...This won't be a drug where a given patient needs to weight up the bad and serious AE's chance versus what benefit it's going to have.

This isn't a drug where the average Joe is going to have to keep taking it day in day out...

This wont be a drug that one really has to decide on taking...

It will be first line (my personal views) and it will eventually be reimbursed to a great extent.



The authority is going to have to be really quite certain before just saying "Go for it man".