Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-864

A timing question of FDA response and the PDUFA date that has been bugging me.

In the past it has taken the FDA/MSB nearly two months to respond and to the BLA submission and announce the PDUFA date. That is noted from past posts by Reg I believe.

Soooo…..

If the review time needed by the FDA is only 2 months for this BLA submission - are the FDA simply going to respond after nearly two months and say approved rather than issue a PDUFA date!

or are the FDA going to change their PDUFA timing response to MSB to be a lesser time this time around, like after 3 weeks a response from the FDA to set a 2 Month time frame.

If 6 months obviously situation is just repeated like last two times - that is known.

Interested to know thoughts on timings on FDA/MSB announcements for 2 month review.