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Uvula and investorsam, just to clarify a couple points: I do think doctors will tend to be dismissive of our White Paper results, but not because of the sample size. Rather, the results are subject to the criticism of not being the result of rigorous study design with double-blinded providers and the presence of a control group. We knew that when we wrote the paper. If you go back to the introductory part of the paper, you'll read a section where we say that Vdex is not a research organization but a diabetes-treatment practice. To reiterate the point, and I think it bears repeating, there are lots of studies with lots of medications that show significant clinical efficacy (some 40 new FDA approved meds for diabetes since 2005) in the controlled, artificial world of an FDA-type study. The drugs are all put through formalized study as was Afrezza. The real problem comes with everyday use in real patients. There is where you see many (perhaps most) diabetes drugs fail, or least underwhelm. Afrezza is just the opposite. The data gathered in the formal FDA trails was underwhelming, but in practice the drug does phenomenally well. In our White Paper we're simply documenting what happens in real-world use of Afrezza. And, isn't this where it matters?

As an aside, MNKD has a treasure trove of data gathered with the Medtone inhaler device showing outstanding results, data that the FDA will not let them publicize in support of the Dreamboat device.

There are lots of ways are White Paper might be criticized as a study, but it cannot be criticized as merely a report of our observations in the use of Afrezza in real-world patients. That's what it is. I guess one might say its just lies. 

I find it interesting how often our outstanding results are criticized, as if there are better results anywhere else. As if PWD are doing so well with existing meds and protocols. We know they're not! The diabetes industry acknowledges that few patients, something like 30%, get to goal of an HbA1c of 7. And 7 is nothing to be proud of. This is well above the point where microvascular damage occurs. So, even if you get a patient to 7, s/he will still have complications. And, by the way, often patients get to 7 for a while but over time as their disease worsens, they go higher. Our goal in founding Vdex was to get them to normal levels or at worst, below the point of microvascular damage which is an HbA1c of about 6.2. We can do this because of Afrezza. 

We really feel the situation ought to be flipped on its head. The diabetes industry ought to be asked to defend what they're doing.

The problem with that is that De Blasio doesn't probably know anything about it so he'll seek the input of doctors and end of story for Afrezza.

Stevil, we've had zero problems. I know that seems hard to believe, but I wouldn't misrepresent this situation. Rapid HbA1c reduction such as we've seen at Vdex really hasn't been seen before. Of course, there's never been a product like Afrezza before. I can't say that we, or anyone else outside of MNKD, fully understands the implications of the use of Afrezza. It's just so different. I've said many times, "Afrezza's at least as good as Al Mann said it was." Further, we discovered some things in our use of Afrezza that were unknown even to MNKD management.

What I'll say in overview, and these sentiments are shared by our Medical Advisory Team, is that the best way to manage blood sugar is the way the body does naturally. As all on this board know, that's what Afrezza does. IMO there's simply no argument for the existing ADA protocol once one understands Afrezza. We've had too many patients come in loaded up on orals, maybe along with GLPs and/or insulin, feeling terrible and apathetic about their condition. Some literally talk about just getting off everything and accepting their fate, which they know means death. You put those patients on aggressive doses of Afrezza and in short order change their lives. This is not hyperbole or salesmanship. You literally change their lives by giving them back control of their condition. Predictably, a whole host of physical and psychological benefits flow from this. This is not because Vdex is so wonderful but because Afrezza is.

I have to disagree with the posts in opposition to bringing HbA1c down quickly. Let me admit that I'm not a doctor, but as the Founder of Vdex along with my very close physician friend, I get medical input on all aspects of Vdex, all the time. I have 3-4 different physicians that I can access quickly. All are in favor of attacking HbA1c levels aggressively. It is true when you bring someone from an A1c of 14 to 7 there is an adjustment period for their body, but that is brief. There can be some "symptoms" of hypoglycemia, but theses are transitory and not dangerous. It's just the body adapting to the new normal. However, the salutary benefits of a more rapid drop in HbA1c are huge. Some, such as much better sleep, really help reinforce the change and keep the patient motivated to improve. I think that in part explains the high compliance among Vdex patients.

A subtle point is the issue of Afrezza's mode of action in reducing HbA1c. Because Afrezza attacks the post prandial excursions, or more accurately stated, preempts them, Vdex gets more bang for the buck with less danger. Here's why: the post prandial excursions where blood sugar levels skyrocket into the 300-400s and more for many patients, are what really drive up the HbA1c values. Since HbA1c is an average of lots of data points, if one eliminates the worst data one gets a bigger effect on the average than if one brought all data points down a small amount. In statistical terms, we're eliminating outlier data. Even if we don't address the basal data we still see a large effect on A1c. But, here's a key point: since we don't initially address the basal data, we haven't so dramatically changed the existing blood sugar state of the patient. I apologize for not making this clearer, but what I'm trying to explain is that there is a statistical effect that is not necessarily indicative of a physiologic effect.

I've never seen this issue addressed in the literature but that may be because never had a product before that could do it. Just one more way Afrezza is ground-breaking

Cjm, nothing has changed from what I wrote a year ago. If anything the situation may be more extreme now. Afrezza faces a lot of systemic resistance in the medical community. We've battled that this entire year. We've made progress, but still battling.

I wanted to jump in with some real world feedback on the issue of script writing.  Don't mean to be a downer, just giving info that board members might find helpful.  We at Vdex interface with a lot of providers and a basic principle we operate under is the more experienced a provider is in the field of diabetes, the LESS likely he/she is to recommend Afrezza. It's obviously not 100%, but the phenomenon is common enough to make the point.  In other words, those most "in the know" have soured on the product. I won't get into why that is; most here probably already know. The most common feedback we get from such providers is: "Afrezza's a niche product." "It's too expensive." "Patients aren't that interested."  Translation for all of these: the provider doesn't really understand the product.

I don't think reps calling on busy docs or TV advertising will turn the ship around quickly, if at all.  The product is so different. The conditions of the industry are so unfavorable. The incentives work against providers.  This product requires a different sales model.  Of course, that's self-serving to say.  But, that has been our experience. I hope I'm wrong and scripts take off in the new year.  But regardless, we'll be fighting the fight either way.