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FDA Places Clinical Hold On Vaccine Trials.(Brief Article)
2001 OCT 3 - (NewsRx.com & NewsRx.net) --
AVAX Technologies Inc. (AVXT), has submitted its response to the Food and Drug Administration's (FDA) clinical holds of the company's M-Vax and O-Vax autologous cancer vaccine clinical trials. AVAX's official reply addressed the issues of sterility, handling of tumor cells, preparation of vaccines by the company, and manufacturing practices, including successful validation of the aseptic fill process.
"We are very pleased that we have been able to accomplish the steps necessary to respond to the FDA, in the time-frame previously communicated, and with the work completed and the effort put forth by our entire team in achieving this important milestone," said David L. Tousley, chief operating officer of AVAX. "We look forward to working with the FDA to achieve a full release from the clinical hold.
"In addition to the work related to our response to the ...
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