FDA approval....19 Jan 2021 10:54
I had confirmation from AGL yesterday that the FDA submission sits within the InVitro category, so I did a bit of digging around those stats from the FDA report.
58% of decisions were ‘granted’, with just 3% declined - the rest were either withdrawn or deleted.
If you exclude those Withdrawn, 88% of decisions were ‘granted’, with just 4% declined
If you exclude those Withdrawn and Deleted, 95% of decisions were ‘granted’, with just 5% declined
So, assuming we don’t withdraw/delete the application (tbh, not sure what constitutes a withdrawal or a deletion), we have a 95% chance that the decision will be granted.
On top of that, if you look at the timeline for decisions for InVitro (have assumed ours is non-LDT?), there were 29 decisions made over 2018/19 - 100% of them we made within the 150-day FDA goal.
So, 95% chance that we’ll get a granted decision with a 100% expectation that it’ll come with their target time.
Include the fact that we followed the Q-Sub process, which should mean the number of Industry days are minimal, I’d say we’re in a pretty good place - both in terms of immediacy of decision and chance of success.