Cytori Reports Summary of FDA Feedback Regarding its ATI-1123 Product
CYTORI THERAPEUTICS (CYTX)
Last cytori therapeutics earnings: 11/14 04:15 pm
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US:NASDAQ Investor Relations:
ir.cytori.com/investor-relations/default.aspx
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Source: GlobeNewswire
AUSTIN, Texas, July 01, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today provided an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. ATI-1123 may have future clinical utility in a number of difficult to treat cancers. The purpose of the Company’s submission was to clarify certain key aspects of the future development plan including: (1) the suitability of the 505(b)(2) pathway for approval of the proposed ATI-1123 drug product, including the proposed listed drug (LD), (2) the adequacy of the referenced clinical, nonclinical and pharmaceutical quality information, in combination with the proposed drug development program, to support the new drug application and (3) any concerns that the FDA may have with regard to other fili
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