ANI Pharmaceuticals (ANIP)

[rgshredder]

I suspect it's going to get delayed.

The FDA had previously reported back in August that a rise in volume of applications and travel limitations has slowed its review process. On time reviews have dropped from 98% in 2020 to 91% in 2021.

I'd love to eat these words, but given the manufacturing asset in Canada, and their borders having been closed, I wouldn't be surprised if it was delayed. I suppose it'll really depend on the details of the application. If any part of the process involves using manufacturing capabilities in Canada, then we may be waiting for the inspectors to get across the border.

To read this another way, don't grab pitchforks if it gets delayed.
-RG