Chaim Lebovits: Thank you very much for this question, Candy. And just a clarification, first of all, very, very happy to hear about your son’s stability in this disease, this is a wonderful news. But we didn’t have two EAP programs, it was the same EAP program that went twice for the same patient. We didn’t clinically — unfortunately, we couldn’t include more patients. We would love to if we had the possibility. So I’m so sorry, we couldn’t include more patients. And we’ve an underlining policy, we know that some of you have not had. And of course, we are very, very strong in our policy that this is not the best interest for the trial in regulatory process to unblind. And I will ask Stacy to really give you a detailed explanation on that, which we already I think passed through your doctors, we’re very happy to this opportunity to tell you directly.
But you should know we have the best interest of ALS patients and we want to do what’s best to get this product in access to patients yesterday. We understand the urgency. And I heard you a lot of questioning that you want to be to talk even stronger at an ADCOM, I get that, but we have this conflict of interest like what’s the best interest of getting this product approved and that’s what we have to focus. But Stacy, please give those professional insight you have from your 25 years in the industry, what old trials do usually? I mean, there are, of course, some that choose a little bit different way, what the norm is Stacy? And thank you again for calling Candy.
Unidentified Analyst: Yes. Thank you for taking my questions.
Stacy Lindborg: Yes, Candy, thank you very much for sharing the background of your son and we are encouraged every time we hear updates in terms of the stability of patients. So I’m thrilled, he’s breathing on his own and able to eat. But let me step back and provide insights into the conversations that we’ve had and really what drives our position right now. So from the time that the trial, the Phase II trial completed, we have learned and have received requests from some participants requesting information about the randomization status. In some instances, as you’re seeking to actually be able to describe what confidence the results that you’ve seen in with your son and the stability that he has experienced, which is unusual in a disease like this.
For others, it’s information that will offer peace of mind or closure on the trial. And we have to say that our first and strongest clinician is to honour these requests. The dilemma that we must confront comes with a desire to provide this level of data has the potential to be detrimental to the overall community. In the sense that it could interfere with the regulatory review. So, we believe this would be the case if we provided patient level randomization, while the regulatory review is underway. And for this reason, we made the difficult decision to maintain confidentiality of randomization. We have evaluated the merits of this decision at multiple times, since the trial completed and we continue to believe that maintaining confidentiality of randomization remains the best decision until the regulatory review process is complete.
