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Atom0aks

11/10/19 11:22 AM

#224049 RE: eightisenough #224039

The fda/panel NEVER voted against a drug which was ALREADY endorsed by all medical org. in that field (nla,ada,adh,acc). In your example the drug was only endorsed by nla at the time fda gave the crl. Also--in Vascepa case the organizations actually included it in their GUIDELINES!! In your drug I do not see such inclusion.

Nice try. Good luck to you.



Again, I don't understand why you think that matters. As you pointed out, AHA and ADA endorsed ezetimibe AFTER the crl.