Registration study means that you’re doing your clinical trial with medicine that is essentially identical to the medicine that you intend to put on the shelf of the pharmacy. So, we’re now at that point where we did the hard work to do the tech transfer, to bring the analytic methods over from China to North Carolina, and validate those methods. We’ve upgraded our control of impurities from a Phase 2 level to a Phase 3 level. So, now that we actually have medicine that we believe is substantially identical to the medicine that we would hope to put on a pharmacy shelf in a couple of years, we’re able to make this a Phase 2b/3 registrational trial. So, that’s not really a protocol change per se. And I think often investors don’t realize how these days in biotech, failures in manufacturing and CMC are possibly more likely to bring down a promising drug than failures in an efficacy trial.
And that’s why we’re so fortunate to have Dr. Panicucci, who is one of the world’s more experienced drug manufacturing experts as our Chief Technology Officer.
Vernon Bernadino: Okay. Got it. And that’s certainly important because conceivably, if it’s a study that are very successful, you could also, and I say, conceivably use the Phase 3 material for commercial supply. I guess what I was specifically getting at is, is there going to be any change to pass the screening of patients such that it fine-tune those that would enter a Phase 3 level type of study that is registrational?
Jonathan Javitt: Well, one of the things that we’re intensely focused on is ensuring that the psychometric ratings achieved in this study are as accurate as possible. There’s been a lot of talk in this psychiatry space about study sites that yield surprising results and getting on top of study sites. And one of the things we’ve done that we think is a little different from what some have done is we’ve built a team of expert psychometric raters within the company who are evaluating in real-time the ratings that are being achieved at the study site. So, they get an audio recording of each rating session as it happens and we’re constantly looking at in accordance between people who are being raided by the site raters on the score on the CTI suicidality scale and those same sessions being evaluated by our in-house master-raters and we’ve set up an adjudication system so that appears more than three points of this agreement, that rating session immediately goes out to an independent adjudicator.
And if you look on clinicaltrials.gov, we published some of our information about how we do that. And I think in the coming months, we’re going to hope to get a scientific publication out that will give the investment community get some sense of how we approach this this whole process of trying to keep a clinical trial under control where you don’t win or lose based on a blood test or examining a piece of tissue, you win or lose based on what’s inherently a subjective process where an expert psychologist is asking structured questions and assigning a score. And keeping the drift between study sites down as low as possible is the difference between having a very high standard deviation and a great deal of difficulty improving statistical significance versus having a tighter standard deviation and an easier ability to prove statistical significance.
So, that’s where we’re focusing every day as we try to do our job to bring this medicine to market.
Vernon Bernadino: Sure. That’s helpful information. And because of the placebo effect, as you know, and the problems with that in these kind of studies, that’s why I asked the question because unfortunately sometimes it’s impossible to know if somebody’s suicidal unless they actually attempt suicide. But in the screening process, you can fine-tune the, like I said, the as well as possible and increase the chances for success. I appreciate you providing that additional information and wish you the best of luck for the study. Thanks for taking my questions.
