So I think we’re, I think, as confident as we’ve ever been about the science that we’re seeing and the likelihood of these events occurring in the future for us, I think are improved particularly with respect to the updated strategic plan and the extension of the runway that we have to focus on those events. Steve, do you want to pick up the regulatory parts?
Steve Pakola: Sure. Hi, Dan, thanks for the question. Yes, interestingly or maybe not surprisingly, this was a discussion point at AAO this past weekend and also some of the ancillary meetings that were held there, the issue of sham-controlled. And I think there’s a couple of key points here that a big component of the FDA’s view on the challenges of masking with a sham control relate to intravitreal injection and that’s due to the fact that there’s a general belief within the FDA, in particular, that getting an intravitreal injection, the patient can actually sense that they’re getting a real intraocular injection and may even be able to see something in the visual axis to suggest that there’s actually been a fluid injection.
So for our suprachoroidal programs, that’s not an issue because we’re not actually injecting into the eye, and we’ve had regulatory interactions we’re aligned on an approach for giving a “shaminjection” that preserves masking. The other aspect that’s come up from the FDA’s discussion of this are, there’s other ways to address this, such as considering having two active arms of different dose level of your given drug that at least then preserve the masking between active arms. So there’s several approaches that companies can consider. But fortunately for us, the fact that we’re not an intravitreal injection really shields us from this issue.
Ken Mills: Thanks for the question, Dan. I guess the level of detail that Steve is giving about thought that’s going into the application of suprachoroidal delivery and later-stage trials is, I think, additional evidence of the work that’s going on inside the company and in the partnership to support these types of things.
Operator: Our next question comes from the line of Vikram Purohit with Morgan Stanley.
Unidentified Analyst: This is [indiscernible] on for Vikram. We have one question for potential partnerships for RGX-181and 381. Do you have a time line in mind for establishing a partnership? What would you be looking for to partnership outside of capital? Thank you.
Ken Mills: As for the strategic update plans today are really focused on assuring and sourcing capital for RGX-314, RGX-202 and RGX-121 to achieve what we think is the strongest potential value that we have in the pipeline today. So with respect to 111 and other things that’s going to be a discontinuation of any clinical development work and exercise that will result in looking for opportunities in the short term for partnering, but it won’t become something that will be viewed as a meaningful contribution to the operating plans going forward.
Unidentified Analyst: Thank you very much.
Operator: Our next question comes from the line of Alec Stranahan with Bank of America.
Alec Stranahan: Thanks for taking question. Just one from me. Could you maybe expand upon the positive FDA interactions you’ve had after the update for 202 dose Level 1 and did you get any input on the pivotal study design as well, particularly as it relates to different age cohorts? Thanks.
Ken Mills: Thanks. Yes. Thanks for the question, Alec. I think that it’s been a very dynamic process for us with respect to contact with the FDA on RGX-202 and that’s because of the landscape of what’s happening in microdystrophin in general. We want to understand how FDA is sort of thinking about our data and other data sets and the evolution of things with respect to microdystrophin as a class. I think for us, incredible opportunity to early on at dose level 1, talk about safety and microdystrophin expression and sort of the pathway to making a dose selection. I think there’s also a lot of interplay that we see on, let’s say, for instance, manufacturing, Alex, right? We’re working through basically BLA readiness for our manufacturing facility and a manufacturing process with 121, that is also something that is a path for us with respect to 202.
And so we’re — I mean, this is for us between an RMAT meeting and interaction around 121 and between the opportunity to sort of update leadership and people at FDA with additional information and data about RGX-202 and also get feedback about what is going on with respect to the landscape of microdystrophin in general. It’s a really rich time. I think that we’re setting us up well for thinking about strategies and operational plans that are about acceleration. And I think the best example of that was just being able to modify the clinical protocol to reduce the number of patients from 3 to 2 before moving into a parallel enrollment scenario with the dose levels that we’re at. I think — that was something that was informed by data. It was informed by safety.
