FDA delay for ph 3 trial approval, page-48

Yes, last time was a 7 full months in the middle of covid...

The FDA were getting smashed because they were busy with emergency approvals in amongst staff getting sick. To try and space things out they went up to the very last day of each and every 30 day round.


This time is very different:

1) We have a Fast Track designation in place

2) We aren't putting in an IND from scratch, we are revising one and this isn't the formal application. This is coupled with a Type D meeting response as well as a proposed revised protocol and supporting data. It has no strict PDUFA timelines.

I suggest it should work in our favour for them to take their time, there will be LESS chance of making us have to do ancillary tests/gathering of spurious (my views) evidence as they are in a rush. It should be a more thorough and genuine analysis of the reams of data we have put forward.



My personal opinions of course.

I genuinely think it can be any day now, though I've been saying that for about 3 weeks to myself now.