Biovest International, Inc. (OTCBB:BVTI), a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), announces that it has made a formal amendment request to the FDA seeking to use pivotal Phase 3 data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission, to gain conditional approval of BiovaxID for treating follicular non-Hodgkin's lymphoma. Biovest has proposed that the data be analyzed as part of the annual Data Safety Monitoring Board (DSMB) review of its clinical trial. If the data show a statistically significant difference in combined molecular and clinical tumor-free survival, then Biovest intends to request that the FDA consider granting conditional approval to BiovaxID. This approval, if granted, would require the company to complete the ongoing Phase 3 study as a condition to continued marketing of BiovaxID.
