I also believe that the agency will approve tofacitinib, as Pfizer did an excellent job on the long term studies and IMHO does have a good handle on the malignancy risk for up to a one year treatment.
Still, the malignancies do concern me since some are non-classical malignancies. But, if I were an RA patient or prescribing doc, I would want limited duration of drug use (not greater than 1 year) due to the apparent time-dependency on drug for the genesis of these malignancies.
I hope the Incyte/Lilly and Galopagos drug candidates' results come quickly for the benefit of RA patients. Very interesting space, obviously. Kinda like some of the early GABAergics for anxiety, sedation and memory, initially starting with non-selective agents and then getting more selective for at least some of the indications. First or second inning for the JAKs, using a baseball analogy.