Shares of MannKind (MNKD) were on the dive after hours on Monday following a heavily-anticipated earnings release that had many investors looking for solid notes resulting from a recent meeting with the FDA regarding the way ahead for the company's inhaled insulin product Afrezza, which was denied for approval in January.
The MannKind conference call following the earnings release revealed that the meeting did take place last week as planned, and the company received a clear path for completing the two additional trials that will be required for the future approval of Afrezza. However, according to comments made by representatives of MannKind, details are still pending from the FDA and the trial protocol is still being finalized.
With the emergence of these new updates, it's expected that the trials would not be completed until towards the end of 2012, with approval now looking like a 2013 possibility. That could be considered light years for investors in the biotech/pharmaceutical...
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