Thursday, January 20, 2011

Mannkind (NASDAQ:MNKD) Shares Crushed on Request for Additional Trials of Afrezza

Mannkind (NASDAQ:MNKD) shares are getting hammered today on the news the FDA has requested more trials for Afrezza.

"The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone inhaler," said Mannkind in a statement.

Mannkind CEO Alfred Mann added, "We plan to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."

The MedTone inhaler is a next-generation inhaler requlators said the company must use in trials to generate more data on how it performs and is used, as well as how its handled and stored.

MannKind was trading at $5.36, down $3.75, or 41.16 percent, as of 11:06 AM EST.

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