Adventrix Pharmaceuticals Inc. (ANX) said Tuesday that the U.S. Food and Drug Administration has rejected its New Drug Application for Exelbine (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.
In its Complete Response Letter, the FDA said, based on inspections at clinical sites, the authenticity of the drug products used in the pivotal bioequivalence trial could not be verified, which placed the results of the trial into question. The letter also said that the bioequivalence trial will need to be repeated to address this deficiency.
"We are disappointed with the FDA's determination and, next week, plan to request a type A meeting to discuss its response. Following that meeting, we will be in a better position to comment on the future of our Exelbine program...", said Brian Culley, Adventrix CEO.
In Tuesday's after hours session, ANX lost $1.40 or 55.12%, on a volume of 1.4 million shares.
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