Therafectin saga refuses to die

The FDA told Greenwich Pharmaceuticals Inc. that two more agency-sponsored evaluations have concluded that the company's NDA for Therafectin lacks substantial evidence that the drug is effective in treating rheumatoid arthritis.

Following the rejection by both an independent review and a supervisory review by the Pilot Drug Division, the company said it accepted the FDA's offer to request a meeting with the reviewers and other agency staff to discuss the NDA. The company said it believes the meeting can be concluded before month's end...