FDA Plays

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INCY ($12.54) - Facts to consider before the upcoming FDA ruling:

1) What is being reviewed by the FDA: New Drug Application for ruxolitinib (INCB18424/INC424)as a potential treatment for patients with myelofibrosis (MF).

2) Fast Track Designation received from the FDA: http://bit.ly/vaaPla

3) Special Protocol Assessment (SPA) reached with the FDA for the COMFORT-I Phase III Study: http://bit.ly/vbyrR9

4) Company ran a second Phase III trial, COMFORT-II, in Europe under the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib. This was done for the purpose of EU filing.

5) COMFORT-I trial meets primary and key secondary endpoints: http://bit.ly/etnwDs

6) COMFORT-II trial meets Primary Endpoint: http://bit.ly/rXt1oZ

7) FDA grants priority review for the NDA: http://bit.ly/s1XRPP

8) PDUFA Date: December 3, 2011