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Biobillionair

10/05/17 11:05 AM

#115582 RE: HDGabor #115574

G- The fact the FDA had the Ad Com and made the allegations and then publicly foreshadowed the rescindment of ANCHOR violated the APA. The FDA has guidance documents to address such procedures, not using those documents is arbitrary and capricious. My "statement" the FDA violated the APA by publicly rescinding a SPA without using the set guidance documents approved by the agency is fact. Had the FDA used the guidance documents a type A meeting would have been scheduled prior to Oct. 16th 2013 ANCHOR rescindment SPA Ad Com. The exact law is the FDA can not deviate from set guidance documents because they feel they could get away with it, this is arbitrary and capricious. The damages are AMRN stock being destroyed.

Google APA. Read Oct. 16th Ad Com. Make a proper conclusion the FDA acted in an arbitrary and capricious manner with the method used to rescind ANCHOR SPA. The actual SPA rescindment right or wrong is immaterial, the method damaged stakeholders.

BB