In a stun­ning about face, the FDA is now wel­com­ing the new drug ap­pli­ca­tion from Alk­er­mes it re­ject­ed 2 weeks ago

Some­body at the FDA just got a rude wake up call.

Just two weeks af­ter the FDA in­vit­ed Wall Street to pum­mel Alk­er­mes $ALKS by re­fus­ing to even ac­cept its ap­pli­ca­tions for the de­pres­sion drug ALKS-5461, the biotech says that the agency has sud­den­ly de­cid­ed to sim­ply change its mind.

Ac­cord­ing to Alk­er­mes, the stun­ning about face came af­ter the com­pa­ny “clar­i­fied cer­tain as­pects of the NDA sub­mis­sion. No ad­di­tion­al da­ta or analy­ses were sub­mit­ted by Alk­er­mes to FDA.”

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