PHILADELPHIA & LYON, France--(BUSINESS WIRE)--AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that AVAX has been cleared to launch its Phase III Registration Study for M-Vax, its AC Vaccine Therapeutic for the treatment of Metastatic Melanoma. As previously announced by AVAX, the FDA has provided the Company a Special Protocol Assessment related to the planned protocol. The SPA is a written agreement between AVAX and the FDA regarding the trial design, surrogate endpoints to be used as a basis of filing for accelerated approval of M-Vax and the statistical analysis plan necessary to support the full regulatory approval of M-Vax.
