Just how understanding can the FDA be?

Intra-Cellular Therapies got good news and bad news yesterday. In one study, its drug significantly outperformed placebo in improving the symptoms of bipolar depression. In a second study, the treatment was basically indistinguishable from placebo.

The company, which blamed the failure of the second study on an uncommonly high placebo effect, still plans to make its case to the FDA. And there’s precedent for regulatory wiggle room: Johnson & Johnson won FDA approval for the depression treatment esketaminedespite a single failed trial among a handful of positive ones.

But analysts say the most likely scenario is that Intra-Cellular will have to hope for positive results of a third study that will read out next year. At that point, the company can point to the entirety of its dataset in hopes of convincing the FDA. It worked for J&J, but when Alkermes took the same approach, things didn’t go so well.