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The three articles linked below are a useful layman's guide to understanding how to navigate the shoals of the FDA's NDA approval processes.
http://www.minyanville.com/articles/4/15... http://www.minyanville.com/articles/4/19... http://www.minyanville.com/articles/5/11... The last article discusses the SPA process. There is no way the legally binding SPA agreement between the FDA and PTIE could have required a "likeability study" (which was ignored by Barbier) and the Remoxy NDA be accepted for filing in its absence. Rating :
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