TORONTO (Reuters) - PreMD Inc lost more than 75 percent of its stock value on Tuesday after the U.S. Food and Drug Administration rejected its regulatory claim submission for its point-of-care skin cholesterol test.
The shares plunged 99.5 Canadian cents, or 76.5 percent, to 30.5 Canadian cents on the Toronto Stock Exchange, well off its 52-week high of C$2.10 in mid-July.
The company said the FDA’s primary grounds for rejecting the claim related to the clinical utility of evaluating skin cholesterol with carotid wall intima thickness as the clinical endpoint.
PreMD submitted the application to the FDA in June 2007 based on a study design that was previously accepted as appropriate by the FDA.
The agency then requested additional information regarding statistical clarification on the data submitted which it said it provided.
The company said it supplied the information “promptly” and believed it addressed those concerns. PreMD also said it was not aware of the FDA’s concerns from previous discussions.
“We believe we have provided adequate information to support clearance and continue to believe that our product merits clearance by the FDA,” Brent Norton, president and chief executive of PreMD, said in a statement.
The company said it would work “as expeditiously as possible” through the process in addressing the decision.
Reporting by Scott Anderson; Editing by Bernadette Baum