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Executive Summary

FDA questions whether M-Vax and O-Vax "are sufficiently developed for ongoing clinical trials to be considered adequate to support a BLA," Avax reports. The autologous cancer vaccines were put on clinical hold in March, at which time Avax maintained that the hold was not related to manufacturing issues (1"The Pink Sheet" April 2, In Brief). Written communication from FDA indicates that the hold is related to Avax' handling of tumor cells, preparation of vaccines and manufacturing practices. An investigation of the firm's Philadelphia manufacturing facility is underway. Exec VP-R&D Ernest Yankee, PhD, and VP-Operations Kamy Behzadi, PhD, resigned at the request of the board of directors

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