Biotech Values

[DewDiligence]

FGEN—Can be spun + or - of course.

AZN’s Dec 2020 PR (#msg-160326895) implied—(although it did not definitively state)—that the impetus for the original PDUFA miss was labeling discussions, so maybe the need for an advisory committee is also driven by labeling. This would be the bullish interpretation.

The bearish interpretation is that the additional analysis AZN/FGEN submitted in response to the FDA’s request in Dec 2020 caused some new issue with the NDA to surface, triggering the need for an adcomm to opine vis-à-vis the newly surfaced issue.

In any event, Roxadustat’s FDA approval is almost certainly delayed for several months beyond the 3/20/21 revised PDUFA date.