I think that the biggest thing coming out of his meeting today is that the FDA does not seem to be questioning the efficacy or the safety. I also think, why don't they just submit the Gen1 inhaler and get approval for the Gen2 at a later date?
Actually I don't even think the Gen2 came out of concerns. It was a function of creating a better device which would have held up hte rest of the submission. FDA said to submit a supplemental upon approval as opposed to amending what had already been submitted.