CAREFUL WITH ACRONYMS HERE. REMS, THE RISK EVALUATION MITIGATION STRATEGY. AND THE OTHER ACRONYM, THE ELEMENTS TO ENSURE SAFE USE. THE BASIC QUESTION...

OWN SYSTEM THAT'S SEPARATE BUT EQUAL. IF THAT PROVISION WERE REMOVED FROM STATUTE THEN POTENTIALLY WE COULD JUST GO TO THAT AND NOT HAVE A DELAY...

THAT WON'T FIX THE INSTANCE WHERE THE INNOVATOR COMPANY IS NOT PROVIDING OUTSIDE OF RECOMMENDS. THEY JUST HAVE A WAY -- OUTSIDE OF REMS. THEY JUST HAVE...