MannKind's Afrezza Dealt Setback by FDA

Apr.12.11 | About: MannKind Corporation (MNKD)

Might the FDA be giving MannKind (MKND) the bum’s rush? Late Friday, the agency cancelled an end-of-review meeting designed to discuss the Afrezza inhaled insulin device that earlier this year was the subject of a second complete response letter. The reason for the cancellation? The potential for a government shutdown. The FDA, meanwhile, did not reschedule the meeting (see the statement).

The move is the latest incident in which at least one Wall Street analyst believes the agency appears to be sending a decidedly chilly message to the MannKind team, which was asked in January to provide more safety data about Afrezza and run two new trials - one with Type 1 diabetes patients and another with Type 2 diabetes patients (back story).

"While the FDA cancelled the meeting with MannKind, we note that other FDA meetings planned for this week will go on as scheduled," writes Hapoalim Securities analyst Jon LeCroy. "As when the FDA failed to give MannKind the official minutes from its meeting after the 2010 Afrezza Complete Response Letter, it appears to us that the FDA is sending a signal that it has no interest in the Afrezza program."

He goes on to suggest that, if the FDA fails to reschedule, this would be seen as "extremely negative" for the whistle-sized device that has generated skepticism, despite the backing of billionaire Alfred Mann. Whether he will continue to unquestioningly invest in further development is unclear (see this), but there is no reason - for now - to believe the FDA will not reschedule. MannKind promises to brief investors next week on its dealings with the agency.

In any event, LeCroy notes that the cancellation will delay the Afrezza program at least two months, which means patient enrollment in the required trials will not begin until August, and completion would not occur for another year. And so, if MannKind refiles the Afrezza submission only two months after completing the trials and gets a six month review, he writes, this would imply a May 2013 PDUFA date, at best. If his estimation is reasonably correct, MannKind followers, once again, need to inhale.

Disclosure: None