Ok, so we know decisions come down within 67 days of CHMP opinion per footnote #1 of opinion.
Thats next Monday or Tuesday depending on how you count (Opinion first published 7/20)
You would figure that the pre-decision run-up traders would start to flee the ship like rats by now. Wouldn't want to get caught on a ship that may sink or sail in a minutes notice. Maybe they all have stop losses in place. My take, if approved, $3.24 is the new long term share price floor.
From the EMA website (sorry I can't link it):
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dacogen, 50 mg, powder for concentrate for solution for infusion, intended for the treatment of acute myeloid leukaemia. Dacogen was designated as an orphan medicinal product on 8 June 2006. The applicant for this medicinal product is Janssen-Cilag International NV. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
Spot on. Between the revenues from Dacogen in MDS and new revenues from AML, should hold $3 going forward. We all know that even with Dacogen going generic, there should be little effect on revenues based on what has happened to Vidaza sales since it went generic in late 2011. One last thing, on the first of the 3 presentations that ASTX just made, Manus@# basically said that approval has been granted. Did anyone listen to the meeting.