This week, MannKind Corporation (NASDAQ:MNKD) published a set of frequently asked questions about the recent clinical trials for its inhaled insulin Afrezza.
The idea inspired me to issue my own questions about the company, using the questions as a crutch to explain my position. Unlike MannKind Corporation (NASDAQ:MNKD), though, my questions are of the rare variety; most have never been directly asked to me:
Can you summarize MannKind Corporation (NASDAQ:MNKD)’s frequently asked questions?
1. The company thinks the clinical trial data is enough to get Afrezza approved. Deerfield, which MannKind Corporation (NASDAQ:MNKD) has a financing deal with, also likes the data. If Deerfield and its consultants were employed by the Food and Drug Administration, MannKind Corporation (NASDAQ:MNKD) would be all set. Unfortunately, while all good signs, there are no guarantees of an approval.
2. The efficacy data for the older MedTone inhaler doesn’t matter (the safety comparison was what the FDA wanted), but in case you were wondering, it worked as well as it has in the past and essentially the same as the new Dreamboat inhaler.
Also, the analyst that said MedTone efficacy data is important doesn’t deserve the title of analyst. I’m paraphrasing, but I think that’s what MannKind Corporation (NASDAQ:MNKD) was getting at with its comment that “it is disheartening that anyone who holds themselves out to be an analyst would use subjective and alarmist language with respect to such a minor result.”
3. The severe hypoglycemia events trended in the right direction for Afrezza versus Novo Nordisk A/S (ADR) (NYSE:NVO)‘s Novolog, but wasn’t statistically significant. As I pointed out after the data was presented, fewer severe hypoglycemia events would have been very helpful for marketing, but in order for MannKind to claim the difference is real, it would have had to run a larger trial to observe more events.
4. MannKind hypothesizes that the relative weight gain comparing Afrezza to placebo in type 2 diabetics has to do with the options that patients had to reduce blood sugar levels. The placebo group could only lower the level by improving their diet while the group taking Afrezza could reduce their blood sugar after a meal by taking the drug, so they didn’t lose weight. The explanation seems reasonable to me, and doctors might buy it as well since, in the real-world setting, type 2 diabetics don’t typically lose as much weight as the placebo group did in the study.