Stryker Slips After Negative FDA Panel Ruling
Wed, 04/01/2009 - 11:28am
NEW YORK (AP) — Stryker Corp. shares declined Wednesday after a Food and Drug Administration panel recommended against approving Stryker's OP-1 bone growth putty for sale. In a meeting late Tuesday, the panelists voted six to one that the product should not be approved for sale because it was not convinced OP-1 is as effective as current bone graft techniques. Panelists were also concerned about the design of clinical studies intended to support OP-1, and had reservations about its safety. Stryker shares gave up 98 cents, or 2.9 percent, to $33.06 in afternoon trading. The FDA is not required to follow the recommendations of its panels, but it often does. Stifel Nicolaus analyst Gregory Simpson said expected the decision, as there was not much reason for the panel to support the drug. "We thought the company's accumulation, analysis, and presentation of the data, and really the entire clinical trial process, was sloppy and poorly done," he wrote in a note to clients. Simpson said he does not think the Kalamazoo, Mich.-based company will give up on the drug because it is still conducting studies of OP-1 in several indications. Stryker did not immediately respond to calls seeking comment.