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Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?


To: Biotech Jim who wrote (2742)5/7/2012 9:24:32 PM
From: DewDiligence_on_SI  Read Replies (1) | Respond to of 3202
 
Are you backing off to some degree from the comments in siliconinvestor.com ? I had presumed you already read the briefing docs when you posted it. Regards, Dew



To: Biotech Jim who wrote (2742)5/9/2012 11:11:08 AM
From: Biotech Jim  Respond to of 3202
 
At the ongoing tofacitinib AdComm meeting, the Agency is now discussing the malignancy risks, and stated a comparison to the INCY approved drug, Jakafi, that was different in terms of long term malignancy risk. My prior statements re lymphoma have just been highlighted. Serious infections also highlighted.

Will this drug get a black box for greater than 1 year treatment due to the increase in malignancy risk? Will they limit dose to 5 mg bid? Will it get a positive vote at all? We shall see.

Edit: Just wanted to add that this is the same committee that heard and voted down the Arcalyst filing for gout flares yesterday.