TLSR: Another name?

MH: Another one I’d point to is a much more controversial call, and that’s MannKind Corporation (NASDAQ:MNKD). It has had two complete response letters from the U.S. Food and Drug Administration (FDA) on its inhalable insulin product, Afrezza (human insulin of recombinant DNA origin), but that was for an older device that the company thought was not approvable due to requirements placed on it by the FDA. The new Dreamboat device is smaller, more convenient and requires less insulin to be inhaled to produce the same bioequivalent blood levels as the previous device. It is a product that can meet the FDA’s requirements. The next event will be phase 3 results, due in mid- to late 2013, the most notable being in type 2 diabetics. This trial basically requires proof that inhalation of the product will reduce hemoglobin A1c (HbA1c or A1c) levels by 0.5% or more. [Note: A1c testing is a standard assay to determine if diabetes is being managed properly; the higher the A1c level, the poorer the blood sugar control.] This should be a relatively low-risk trial for the company.

I’ve followed every comment the company has made in the last several years and every filing that it has produced, and I do not see any reason why the FDA won’t approve Afrezza with the new Dreamboat inhaler in early 2014. From there, it’s an inhalable insulin competing with subcutaneous injectable insulins. So far, the data we have seen with Afrezza show no change in weight or weight loss versus the rapid-acting analogs that are injected. The biggest benefit will be the ability to pull a whistle-sized device from a pocket and take a brief inhalation versus taking out a pen and sticking yourself three times a day.

http://marketplayground.com/2012/12/20/michael-higgins-on-biotech-names-with-major-market-potential-anx-cytr-bdsi-endp-rbgpy-ttnp-mnkd-nktr-pfe-akrx/