Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post dosing).
There are an amazing number of small biotech that are amazingly bad about very straightforward clinical trial basics. Here underpowering for something that would otherwise have high likelihood of success. GTHX is another company that has a compound and indication where the result is almost certainly potent (TNBC) - but then they made a variety of poor decisions in ph3 design:
a) The ph3 is actually two ph3s in one trial - one based upon a ph2, the other based upon chasing IO dreams.
b) They chose to take forward the worse performing cohort of the ph2 into ph3. 1st Line had a nice OS HR, but still much less than 2nd and 3rd line. Yet they chose to take L1 forward.
c) Assuming half of the split ph3 is for the 1st line patients then they probably are a little above 50% powered for the ph3 (assuming they can replicate the ph2 cohort - always an additional risk)
Separate note related to SEEL: Major Depressive Disorder is getting a lot of potent new treatments that make the older treatments look weak. This is oddly not noticed as much as you'd expect outside some weird niche interest in Ketamine.
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