as i mentioned before...if there is open communication between msb and fda....why would'nt msb,have all the boxes ticked by the fda,without the need for the time frame of the submission..?..no doubt some know the workings of fda better than i....but certainly,if i were msb,,,i'd be wanting fda to tell me that everything is hunky dorry,...before the formal application.
if i'm proved correct...it would'nt surprise for a quick approval,on the formal submission.
as i mentioned before...if there is open communication between...
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