Whether the efficacy was ever shown with medtone, is irrelevant at this point in time with regards to dreamboat and 30% less affrezza, even if a graph on a machine emulating a human lung shows differently. Thus the second CRL.

This would be due to the fact that efficacy has yet to be established using Dreamboat and 30% less afrezza which the current trials will prove using humans rather than machines, and the dosage variations will be monitored and adjusted by doctors monitoring patients now on Dreamboat and 30% less med.

The efficacy of 30% more affrezza inhaled via Medtone has been proven from my understanding based off the nixed trials. But in FDA's terms, that is not going to be adequate when a different system at this point is going to be marketed.

30% less affrezza certainly has the potential to cause a different response to those taking the medication with regards to previous Phase III trial results under the medtone, especially with a different inhaler. Unless of course the other inhaler is in fact 30% more efficient which I could certainly see as the case here.

This is where i see that big time investors would have a hard time risking the investment until conclusive results are released with regards to exactly what will be marketed. No one likes a Phase III bait & switch, but trial results & FDA approval speak for themselves with regards to this new dreamboat and experimental afrezza.