Replies to post #193253 on Biotech Values

[DewDiligence]

EGRX addendum—Evidently 505b2 applications without priority review still get a 10-month review (counting from the submission date, not from the FDA’s acceptance date). EGRX submitted the Bivalirudin NDA on 5/20/15 (#msg-113852714) and announced today (on the CF webcast) that the PDUFA date is 3/20/16.

(EGRX didn't PR the FDA's acceptance of the NDA, but they might do that tomorrow morning.)

[DewDiligence]

EGRX—FDA accepts 505b2 NDA for ready-to-use Angiomax:

http://finance.yahoo.com/news/eagle-pharmaceuticals-rtu-bivalirudin-nda-110000493.html

EGRX previously disclosed that the PDUFA date for this NDA is 3/20/15 (#msg-115257302), so today’s PR offers no new info.