<<I reiterated these sentiments three weeks ago in #msg-52731692 and was surprised to find that some posters disagreed. Fortunately, the FDA and I appear to be on the same wavelength :- )>>
Yes, well, at that point the various briefs had not been drafted. I expect that Department of Justice follows your postings here for a variety of reasons and made their arguments after reading your reasoning.
wouldn't this mean that if Teva's product does not show immunogenicity it will be approved because if there is no immunogenicity it defacto proves purity?
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