BioBill, you've been in contact with FDA Ombudsman correct? Maybe mention how the division level never even replied to the list of questions submitted by AMRN during the appeal, such as "what is the public health risk that justifies SPA recission"? (paraphrased).
When I listened to the CC I couldn't believe that FDA didn't bother to even address the company's reasonable queries on how this was possible to move the goal posts.
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