Jonathan Javitt: Patient enrollment, data analysis, and we announced after the Type B meeting with FDA that they want to see a safety database of 1,500 patients. Now, if you look at recent approvals, approvals actually happened at a smaller safety database than that, but 1,500 is the E1 Treaty target in the United States and other countries all sort of agreed on the safety database size for drugs to treat non-lethal conditions. This, of course, is a lethal condition. And you’ve seen us talk about how we’re going to start building that safety database not only through our clinical trials, which take a while to enroll and are expensive to enroll, but also through an expanded access program that would allow doctors who have patients with bipolar depression and have exhausted approved medications for the treatment of bipolar depression to gain access to NRX-101.
And there’s a fair amount of precedent for the use of such expanded access programs in this way. So, to the extent that people imagine the safety database will be horribly, horribly expensive recognize that when we did expanded access in COVID, it was on the order of $3,000, $4,000 a patient as opposed to the kind of costs one would associate with a formal randomized controlled trial. Now, we don’t know what standard access is going to cost us in NRX-101 yet. We don’t know whether we’re going to be able to gain reimbursement for expanded access, which if you look in the FDA guidance, can be applied for, but we do see it as an efficient way to get to the NDA, while at the same time, continuing our clinical trials for safety and efficacy full speed ahead.
Stephen Willard: Thank you, Jason.
Jason Kolbert: Understood. Thank you.
Operator: The next question comes from Vernon Bernadino from H.C. Wainwright. Please go ahead.
Vernon Bernadino: Hi, everyone.
Stephen Willard: Hey Vernon.
Vernon Bernadino: Congratulations on the progress and thanks for taking my question. Hey, Jonathan, Steve, and Seth. What is important for me to perhaps ask about is with the current trial being upgraded to a Phase 2b/3 study, that may be used for registrational filing. With the nuances of this patient population and how they’re treated, are there any specific changes that are going to occur or need to occur that it has been upgraded to a registrational study or is it just nearly an upgrade because that’s something that you’ve asked for and you’ve already fulfilled the requirements?
Jonathan Javitt: Well, one of the things we did is posted the protocol on clinicaltrials.gov and that’s an important thing to do because when — and we certainly hope the trial will show efficacy. The reviewers for the scientific journals want to see that we were transparent upfront about what are our endpoints, how are we measuring them. So, that to the extent that there are changes along the way, those are known in a transparent manner. The main difference for us between simply Phase 2 and Phase 2b/3 is as I said to Jason, when we started this, all we had in our warehouse was Phase 2 investigational medicine that was made five years ago in China during our partnership with Wuxi Apptec and that’s not investigational product that can be used for registrational purposes.
