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NDA Rejection of Exelbine (ANX-530) - form over substance

ABSTRACT:  The future of the Exelbine™ development program at Adventrx was placed into question when the U.S. Food & Drug Administration (FDA) issued a complete response letter (NYSE:CRL) rejecting the Exelbine new drug application (NDA).  The lack of retained study drug samples at clinical sites does not place into question the results of the bioequivalence (BE)/pivotal trial and is insufficient basis for the FDA to deny approval of the Exelbine NDA and/or to require a repeat trial.  The FDA has ignored other available, clear and convincing evidence of study drug authenticity, has abused its discretion under the related rules, and has rushed to judgment in the instant case.  Requiring Adventrx to repeat a BE/pivotal trial just to obtain redundant and/or unnecessary evidence of study drug authenticity would be arbitrary and capricious Agency action and a clear abuse of discretion.  The recent CRL is an example of "form" triumphing over "substance" and is not in the public interest. 



pbd@entheologic.com