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.
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