ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Silvr, regarding Libi, I was looking at the timeline for the FDA approval of Orilissa (Elagoix) a collaboration with Neurocrine led by Snabes as Sr, Director of Men and Women's Health. There was 9 months and 8 days between submitting a Certification to delay submitting results and AbbVie announcing that a PDUFA date for Orilissa had been set. Orilissa was approved 3 months and 16 days.

If Libi keeps a similar timeline, AbbVie may announce PDUFA date around the first week of August. Abbvie is estimated to announce earnings July 29th. However, I would expect them to time it with the PDUFA date being set. This would lead to a possible approval going into Christmas. Exactly what they need to counter biosimilar competition starting in January.

If this is the case, they have left no room for error. Leading me to believe, the evidence is very compelling.

GLTA