MannKind Corporation (NASDAQ:MNKD) Waits For FDA Committee Meet


Dallas, Texas 02/11/2014 (FINANCIALSTRENDS) The $2 billion market capped MannKind Corporation (NASDAQ:MNKD) announced earlier this week that it will release 2013 4Q and full year results on 18th February. Long term investors in this stock would be hoping that the management team would have more updated information on how the scheduled meeting with Endocrinologic and Metabolic Drugs Advisory Committee would be shaping up; when it meets the press post the earnings call.

It is appropriate here to note that in the second week of January, MannKind Corporation (NASDAQ:MNKD) had disclosed that the Endocrinologic and Metabolic Drugs Advisory Committee which is a advisory body which provides technical inputs to the U.S. Food and Drug Administration on the new drug applications and its attendant clinical trial data, has set 1st April as the review date for drilling into the New drug application filed by the drug firm for its target drug AFREZZA(R). This drug is a big ticket human insulin generator which can be administered to patients in a inhalation/ powder form.

MannKind Corporation (NASDAQ:MNKD) had reapplied its new drug application for AFREZZA(R) with additional clinical data in October last year, after its original application had been sent back by FDA seeking new data to support its claim earlier in 2013. The last date as per statutes, for the Endocrinologic and Metabolic Drugs Advisory Committee to complete its review is 15th April. The application seeks to get FDA buy in to offer AFREZZA(R) as an inhalable drug by patients suffering from “type 1 or type 2” diabetes in U.S.

Valencia, CA based MannKind Corporation (NASDAQ:MNKD) has guided its flag ship development product AFREZZA(R) through 3 phases of clinical trials and hopes to get the green light by the screening committee this time round. It is important to note here that the advisory committees findings are not binding on the FDA.

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