Champs & Chumps ..........Stock Market Winners & Losers

Tuesday, October 17, 2006

Stock Market Chumps..........10-17-06

Cytomedix Inc. (GTF)

Last Trade:1.10
Trade Time:12:49PM ET
Change:Down 1.65 (60.00%)
Shares of Cytomedix Inc. lost more than half of their value on Tuesday after it said U.S. regulators denied the company's claim on a gel for healing diabetic foot ulcers.

A unit of the Food and Drug Administration denied the claim that Cytomedix's AutoloGel is substantially equivalent to a legally marketed device, the company said in a statement.

The primary grounds for the rejection appeared to be the use of bovine thrombin, a clotting agent derived from cows, in the gel, the company said.

Bovine thrombin is used on humans in surgery and other instances to stop bleeding, but the FDA body cited studies that said it could also lead to a bleeding tendency, the company added.

Cytomedix said it will appeal the agency's decision and expects the process to be completed in 60 to 90 days.

The company's shares were down $1.46 at $1.29 in morning trade on the American Stock Exchange.

Neurochem Inc. (NRMX)
Last Trade:15.94
Trade Time:12:55PM ET
Change:Down 2.19 (12.08%)
Neurochem Ltd., a unit of biotech drug developer Neurochem Inc., said Monday it replied to a Food and Drug Administration "approvable letter" for its drug candidate Kiacta.

Kiatca is meant to treat Amyloid A amyloidosis, a group of diseases that can destroy the kidneys when organs accumulate deposits of abnormal proteins.

The Canadian company said it received the letter in August from the FDA requesting more information on the drug to approve it. Neurochem filed the application with the agency in February.

The response, according to the company, included about three years of follow-up data on 183 patients enrolled in a mid- to late-stage clinical trial.

Neurochem said follow-up data showed that fewer patients taking Kiatca progressed to end stage kidney disease or died compared to those given a placebo.

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