On its quarterly conference call Monday, MannKind said the design of two clinical studies of the Afrezza diabetes device were still being finalized, and as such, neither study would likely be completed until the end of 2012, based on current estimates.
MannKind's timeline estimates stopped there, but some simple math and common sense says the U.S. Food and Drug Administration isn't likely to be in a position to issue a third approval decision until the second half of 2013. Even that estimate might be too optimistic.
That's a further slip in the Afrezza development timeline of at least 6-9 months from the last time MannKind updated investors in February.And not to belabor the point, but MannKind's current cash and borrowing capacity runs out in the first quarter 2012. On Monday's call, MannKind founder and CEO Al Mann said he remained committed to the company and is exploring ways to raise additional money. Mann has famously boasted of investing more than $1 billion of his own fortune into MannKind but on Monday, just like last February, Mann would not commit specifically to opening his own wallet again. MannKind finds itself in dire straits because FDA has already rejected Afrezza twice. The company met with regulators last week to reach an agreement on two new clinical studies that MannKind claims will collect new efficacy and safety data sufficient for FDA to eventually approve the device. Analysts and investors on Monday's call spent most of the time quizzing MannKind executives about the details of these planned clinical studies. The particulars are important although less so than the fact that for investors MannKind is dead money personified -- Afrezza is years and two risky clinical studies away from earning a third trip back to FDA and MannKind doesn't have the money right now to get there. MannKind shares closed Monday at $4.40 but fell 11% to $3.90 in the after-hours session. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com.
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