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Biotech / Medical : CRIS, Curis (formerly CBMI) -- Ignore unavailable to you. Want to Upgrade?


To: Jim Oravetz who wrote (357)1/30/2001 12:31:56 PM
From: Jim Oravetz  Read Replies (1) | Respond to of 668
 
CAMBRIDGE, Mass. -- Shares of Curis Inc. were off 48.1%, or $6.25, to $6.75 late Tuesday morning, following news that the company's OP-1 implant for fractures of the tibia received a "Not-Approvable" letter from the Food and Drug Administration.

In a press release Tuesday, the medical technology company said its licensee for OP-1, Stryker Corp. (SYK), received the FDA letter, which cited statistical reporting problems in the Pre-Market Approval application.

Stryker reported the FDA letter Jan. 29, but did not mention Curis as the licensee.

The FDA recommended that Stryker conduct a new study, and the company intends to continue to pursue approval and hopes to meet with the FDA shortly, Curis said.

New York Stock Exchange-listed shares of Stryker traded recently at $46.36, down 56 cents, or 1.3%, on composite volume of 641,500 shares. Average daily volume is 900,907.