OPC,

MannKind is talking about 2-3 months to prepare for submission.And last time I believe that they submitted in June,the FDA accepted it on July 20,2010,and they set a PDUFA date for December 29,2010.So the PDUFA was only 5 months after they accepted it.I too think that they MIGHT still get a PDUFA in the first quarter of 2014.However, I can't figure out why it would take 3 months to prepare for submission.

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Hakan S. Edstrom - President, Chief Operating Officer and Director

I would say that with the initial activities that we have now underway, we are still very optimistic in regards to the fact that we will be able to complete the trials in early 2013 and, say, about 90 days following that to be able to submit the NDA to the FDA. So we are not really changing our targets in regards to be able to submit the application, say, in the first half of 2013 based on where we stand today.

http://seekingalpha.com/article/575761-mannkind-s-ceo-discusses-q1-2012-results-earnings-call-transcript?find=fda&all=false