PHILADELPHIA & LYON, France--(BUSINESS WIRE)--AVAX Technologies, Inc. (OTCMarket: AVXT.OB) today announced it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the initiation of a registrable pivotal Phase III clinical trial for M-Vax, the Company’s AC Vaccine technology for the treatment of patients with metastatic melanoma. 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.
