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发帖数: 2252 | 2 MannKind Says FDA Review Of Afrezza To Take Four More Weeks
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MNKD 7.97 0.00%
As of 4:00 PM ET 12/27/10
DOW JONES NEWSWIRES
MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of
its new drug application for its inhaled-insulin product for diabetics will
require four additional weeks.
The biopharmaceutical company, which has no products on the market currently
, had been expecting FDA approval of Afrezza by Wednesday.
MannKind has been hoping to succeed where larger drug makers have failed. In
the mid-2000s, several companies were seeking to bring an inhaled
formulation of insulin to market as an alternative to injections.
The FDA initially had sought more information from MannKind in March about
how the available data support the clinical utility of Afrezza in the
marketplace, though the company at the time still planned a 2011 launch of
the product. The FDA accepted its resubmission in July.
The company also was dealt a setback in November when a former senior
manager accused the drug developer of unlawful practices in its conduct of
clinical trials, an accusation the company denies.
Shares closed Monday at $7.97 and were inactive premarket. The stock is
still down 9% this year, though it has recovered some of its losses since
the FDA's action in March.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; T*********[email protected]
(END) Dow Jones Newswires
12-28-10 0713ET
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