ALKS 's NDA filing for its Major Depressive Disorder treatment received an unusual treatment from this FDA. Speculation about the reasons for this unusual treatment are divided into two camps.
FDA initially issued a Refusal to File for ALKS-5461. Later, it reversed course and issued a PDUFA date for
It is possible that the Refusal to File was simply a matter of a small mistake in the electronic filing. Others believe it had to do with the fact that ALKS-5461 is supported by only one positive late-stage trial out of three.
Peak sales for this compound could be ~$1B.
This is the kind of issue where the input of the unwashed wretch Feuerstein would be informative. Although he is disinformational FILTH, his ideas govern trading at critical times in biostock movement.
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