RE: CANDLESTICK9 Feb 2021 23:27
FDA Calendar Days are the days that the FDA are actively reviewing the application.
At the point that they ask AGL to provide information, the âclock stopsâ and doesnât start again until the info is provided.
In recent history, FDA Days account for about 60% of the overall time, with Industry Days (time that theyâre waiting for a response from the companies) around 40%.
So, they are targeting 150 FDA Days (which is a goal, but may be impacted by Covid), but expect that time to be significantly extended based on the Industry Days. Hence AN stating Q2 at the earliest.
Personally, I donât see anything coming back until May (my personal guess is May 4th), but as we donât know how many (if any) âclock stopsâ there have been / will be, we are all in the dark.
It could be next week, it could be September. As long as it gets cleared, Iâm good with either, and anything in between!