Bolio..."I am holding hope that the FDA will consider mitigating factors before approval, regardless of Hikma/Reddy readiness."
One mitigating factor might be that the FDA, itself, was unbelieving that the Marine study could show that EPA could lower trigs in patients with over 500mgms/dcl WITHOUT increasing LDL(and thereby lower the incidence of cardiovascular events)... At the Anchor Adcom the FDA all but directed the panelists to say they did not believe this either...the panelists then followed the lead of the FDA with their negative vote.
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