The FDA has told Greenwich Pharmaceuticals Inc. that furtheranalysis is required of Phase III trial data for Therafectinbefore determining whether to proceed with filing of a newdrug application for the drug, the company announced Friday.
Therafectin, a synthetic carbohydrate for treatment ofrheumatoid arthritis, is the company's first product.The Fort Washington, Pa., company said the FDA also willrequire integration of the trial results into the existingTherafectin data base before taking further action.The announcement came late Friday, and the stock(NASDAQ:GRPI) closed unchanged at $11.13. The shares weretrading above $15 in mid-April when the company madenoncommittal statements about its evaluation of the trial dataand deferred further announcements until after the FDAmeeting last week.
Syntex Corp. has marketing rights to the compound.
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