Sometimes clinical improvements are hard to measure accurately and consistently - only through trial and error can you determine the best way to measure the benefit. They said on the call that the additional Phase II trial they will have to run will cost an incremental $10M and delay the clinical path less than 6 months - meanwhile the market cap was scalped by over $300M - seems out of line? The consensus seems to be that the drug is effective, so if they get the trial design down, the value should be realized?
It's hard to see how you could get a valid scientific result in a trial where 35% of trial participants either left town or went on cocaine or heroin during the trial or dropped out for non-related health reasons. There has to be a better way to run a drug trial! This is just #$%$ money away.
I don't think that is uncommon in this field - most trials for depression or other psychiatric/mood disorders are designed to assume a fairly significant drop-out rate - people get into the trial and hope to feel better and when they don't, assume they are on placebo and drop out. Not much you can do about it.
I was thinking this same thing. The AIMS is a difficult test to administer with clinician variability. I like that future studies will take that more into account. And also higher doses. Tetrabenazine is a drug where sometimes high doses are used. I was wondering if the dose of 50 mg daily would be too low. Increasing the dose to 100 mg+ should also help!