As individuals, people react in various ways to the same situation or event. This also rings true when it comes to effectively treating conditions such as depression or anxiety, which often makes it difficult to determine whether treatment is working.
The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.
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