Once I understood that the FDA's question concerned the difference between the mechanical mixing pressure of the GO device vs the manual and variable mixing pressure of the ease of use device, the delay seemed a bit capricious. The data confirmed the GO device works as well as the existing device, in which case the question is superfluous. Does it not seem so to you?
I've seen the FDA throw up needless roadblocks before. Cases where the trials met or exceeded endpoints and had overwhelming support by a panel of experts (which can be convened at company request and expense) and still get a CRL requiring further trials, very costly and time consuming. Hopefully that's not what's going on here.
Once I understood that the FDA's question concerned the...
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