Published in Cancer Weekly, March 4th, 2003
Fast Track designation is intended to expedite the regulatory review and approval process for a product and claim that addresses a significant unmet medical need. The company is in Phase III clinical trials in the U.S. and overseas with AES-14 treatment during chemotherapy for breast cancer. Aesgen plans to submit a New Drug Application (NDA) to the FDA in 2003 under this Fast Track...
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