pennyman,
if I remember correctly at the meeting with USFDA last year this path was recommended by them . Before that Prr had no knowledge of its existance, that is a quicker path existed for treatments where there is deemed to be a serious need and no existing treatment.
That is why prr said they got a good positive hearing, infact they were given some direction by USFDE as to how to make future approaches.
asx ann:martin rogers is catching an aeroplane, page-48
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