The FDA issued the first complete response letter rejecting the sNDA last June.

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We continue to believe that the FDA is highly likely to issue a second Complete Response Letter to MannKind.

FORBES: FDA Delay Could Be Very Bad Omen For MannKind

The initial complete response letter, which was issued in the spring of 2010, cited risk management and manufacturing issues.

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Reader and Arena Pharmaceuticals investor Charlie Brothers e-mailed me with this question today in response to my Arena post on one sentence in the complete response letter.

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According to the companies, the FDA sent a complete response letter regarding the trial-stage drug Horizant, which is in the form of an extended-release pill taken to lessen pain caused by the condition.

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The FDA had initially declined to approve Zioptan, sending Merck a "complete response" letter in November asking for more information about the new drug application.

WSJ: New Drug Approved to Treat Eye Condition