Replies to post #243231 on Biotech Values

[DewDiligence]

APLS—The priority review would seem to eliminate case #2, no?

[WorstLuck]

APLS

Ran across the below analyst comments without attribution to source. It would suggest scenario #3 can be distinguished from #2 and may be in play. No position.

https://twitter.com/whatprobability/status/1575540550064742400

[WorstLuck]

APLS

FDA approval decision for Apellis Pharma’s eye disease drug delayed to review more clinical data.(24 month data)

The review period was extended three months.

Several possibilities here.

Think it's obvious that there were at least a couple other possibilities for the lack of an advisory panel.

As mentioned in another post, that division is not necessarily going to convene a panel (unless it can be done in person.)

And, it has the appearance of a CRL without this additional data, as the data could have been used later as a label expansion.

So basically all bets are off, but this has to improve their odds.