Biotech Values

[DewDiligence]

FDA extends Tofacitinib PDUFA date 3 months to 11/21/12, as expected:

http://finance.yahoo.com/news/u-food-drug-administration-extends-123000572.html

The 3-month delay was expected because PFE said so on its 2Q12 CC in July.

Tofacitinib has an 85% chance of approval on the first review cycle, IMO. I concur with genisi’s assessment in #msg-75539892—i.e. the unmet medical need will trump the ambiguity wrt Tofacitinib’s results in the (non-primary endpoint) of radiographic progression relative to the control arm.

I expect the FDA to grant Tofacitinib a third-line label; if the FDA grants a second-line label, it will be a pretty big win for PFE.