I just finished giving it another read-through. Shkreli tries to make 10 points, but probably the 1st two are the most important.

Point #1, he claims every Phase III trial of Afrezza has failed. He throws out all sorts of data from 6 trials which may or may not be of consequence. It's all out of context and without the study designs or details, I really can't comment. We do know that since this letter and the subsequent CRL, MNKD had meetings with the FDA. Presumably they ironed out what needs to happen in the currently ongoing studies to address any past issues.

Point #2 refers to changing inhalers. And yes, he absolutely has a point here. FDA's own rules state that the new device has to be shown safe and effective in humans. Merely showing that it delivers an equivalent dose (bioequivalence) is not enough.

#3 - he claims no pressing medical need. If MNKD can show better A1c, decreased hypos, better compliance due to ease of use, etc, etc, - then this is moot.

#4 - brings up Exubera FEV1 changes and cancer risk. I think these will be put to bed soon with the follow-up studies. Besides, Afrezza is NOT Exubera. Different drug, different carrier.

#5 - I believe refers to some disgruntled whistleblower.

#6 - refers to efficacy. Will be addressed in current trials.

#7 - Trust - just BS.

#8 - claims of "fast-acting". More BS. Pharmacokinectics have already been demonstrated. He cites 1 paper that apparently thinks tight control is not so good. Huh??

#9 - FDA requires that 2500 subects be exposed to the new drug. I have no idea how many so far, but hopefully with the new trials, this should not be an issue.

#10 - Basal insulin confounding factor. Current studies should knock this out.

Keep in mind, I'm no expert at clinical trials, and I don't have the actual studies in front of me. We all know the device is the major issue. But this and all the other points can be put to rest - especially if a significant number of study participants like AU have similar results. Though we don't hear much, what little we've heard on newscasts etc has all been positive.