Hi @Techinvestor have you any FDA references that support your...

Thanks @LearningEachDay for digging up the Standard Operating Procedures regarding the timing of the labelling process. I too recall that SI said sales can commence immediately after approval.

I too thought (in contrast to @Techinvestor claim) that labelling was part of the overall approval process (i.e. once approved good to go - no need to wait to finalise labelling discussions post approval). Therefore IMO we can hit the ground running.

Also I found this FDA passage to support that labelling is part of the approval process and occurs prior to approval:


https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines

Hi @Techinvestor have you any FDA references that support your proposition that labelling would still need to be finalised in the months following approval?

The only logical reason I could envisage the labelling process happening post approval would be for a label extension of an already approved product. But this is not the case with aGvHD (i.e. potential new approval - or should I say likely new approval)