The Food and Drug Administration is expected to review MannKind Corp.’s application April 1 and issue a ruling by April 15, the company announced Friday.
The Valencia pharmaceutical developer has been trying since 2011 to convince the FDA to approve its invention, an inhalable form of insulin that helps with type-1 and type-2 diabetes.
The only drugs currently available to sufferers must be administered through injections.
Founded and funded by billionaire biomed investor Alfred Mann, the company has twice been denied approval for its candidate product, Afrezza. MannKind spent the last two years conducting more clinical trials, and most analysts think the third time will be the charm.
It’s seen as a make-it-or-break-it moment for the company, which has not yet brought any product to market.
MannKind’s share price tumbled about 17 percent on the news of the April 1 date, which doesn’t make much sense because that’s what was expected. Most likely, the drop was a natural reaction to an unexplained 16-percent run-up in the share price the day before.