Minerva Neurosciences Inc Q4 2020 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Apologies for the background noise. This is a clarification question. I believe for the mITT analysis to be sort of accepted by the FDA that, that would be a process of review. But out of the Type C meeting, they're actually stating that the NDA, in its current format, would be unlikely to be filed. So that would mean that it wouldn't get a review. So my question is, is that the correct interpretation? And then was the unwillingness to recommend a filing, or acceptance of that filing, was that just due to the fact you didn't have this open-label safety data set on hand and now you're ticking the boxes and you have everything in place? Or am I completely missing sort of you reporting that?

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Yes. Understood. That's very helpful. And my second question is just on the bioequivalence study. I understand the last time you were talking about that to us, it was around about 36 patients, and now it's gone up to 48. Is that just an additional cohort for the commercialization formulation? Or is there added patients for some other ratio in that trial?

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : (inaudible)

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Great. (inaudible) interactions with the FDA, and looking for (inaudible) provided valuable data.