Yet another FDA review for Therafectin

Yet another FDA review for Therafectin Greenwich Pharmaceuticals Inc. (GRPI) received a letter from the FDA indicating that the agency will undertake a further review of Therafectin, the company's lead product candidate for the treatment of rheumatoid arthritis.

GRPI has failed on two earlier occasions to gain FDA endorsement of Therafectin. Last September, the FDA told the company that the drug was not approvable because the treatment effect shown in an earlier clinical study was not repeated in follow-on trials. And in January, GRPI presented its case to the FDA's Arthritis Advisory Committee, which voted not to recommend the drug. ...