India, Sept. 8 -- X4 Pharmaceuticals (XFOR) announced positive outcome of Type C Meeting with the FDA related to the global 4WARD Phase 3 clinical trial. The purpose of the meeting was to gain alignment on a revised sample size and associated statistical power and the size of the safety database to support a supplemental new drug application for mavorixafor for the treatment of chronic neutropenia in 4WARD. The FDA agreed that the reduction in sample size for the 4WARD trial from 176 to 126 participants maintains adequate overall power for the co-primary endpoints. Also, the FDA indicated that the proposed safety database would be acceptable to support a potential sNDA.
Adam Craig, Executive Chairman of X4 Pharmaceuticals, said: "We are pl...