August 4, 2009

From The News Wire: Son of a Bong

Ok Ok that title was just fun to write.

For those more interested in toking than shooting your insulin: MannKind Corp's August 3 Earnings Call is up on Seeking Alpha. I freely admit I am not a close follower of the inhaled insulin industry.

Here is the bit that grabbed my eye:

Hakan Edstrom

Thank you, Matt, and good afternoon.

During the last quarter the most significant event was certainly the acceptance by the FDA of our NDA submission. The acceptance occurred on May 16th and we actually received our 74-day letter about 10 days early. Thus, our [inaudible] date is now January 16, 2010 and we are now at the stage of fielding questions from the agency. To date, the questions have been very straightforward and consistent with our expectations. We are encouraged by the interactions with the FDA.

We're also preparing to meet with the agency in order to discuss our development plans for the next generation device, which we recently disclosed on our website and in an interview with CNBC. We have already evaluated this next generation device known internally as Dreamboat, in two Phase I clinical studies. The first of these studies showed that the Dreamboat device is quite insensitive to inhalation technique and supported by a simple patient instruction program using a DVD. The studies have shown that inhalation of 20 insulin units with AFRESA administered with the Dreamboat device produced plasma insulin concentrations comparable to the administration of 30 units using the current Medtone device.

We plan to discuss with the FDA the definitive bioequivalent study design and to map out the approval pathway for the Dreamboat inhaler for use with AFRESA. We are very excited about this next generation device and would like to get it into the hands of patients as quickly as possible.

I did skip over to MannKind's web page and this thing looks a lot less like a bong than Exhubra did.

No comments :

Post a Comment