They still have a reading frame and they can make dystrophin. 9001 is different. Dr. Rodino-Klapac along with her partner, Dr. Jerry Mendell, worked for well over a decade to purpose build a construct that would be shortened, deliverable but functional. And in the end, they were able to not only do that, do it safely and do it in a way that creates a robust amount of expression and our position is protection. So there’s my long-winded answer to your very simple question.
Operator: Our next question comes from the line of Judah Frommer of Credit Suisse.
Judah Frommer: Just curious if EMBARK came up in any way in the mid-cycle communication and if so, in what context? And kind of same question for conversations, pre-commercialization conversations with payers. Is EMBARK coming up as a topic of conversation there?
Doug Ingram: As it relates to the mid-cycle, there was no explicit discussion in the market, the mid-cycle. On pre-commercial discussions, certainly, we discussed the entire program and it includes the confirmatory trial, EMBARK. So yes. Dallan, if there’s anything I missed there, let me know.
Dallan Murray: No, that’s exactly right.
Operator: Our next question comes from the line of Gil Blum of Needham.
Gil Blum: One quick technical. Isn’t May 29 a holiday? Doesn’t that have any effect on the filing? And the other question I have is, do you think the payer pathway is going to follow closely kind of the road map set by Zolgensma?
Doug Ingram: So on the first of, yes, it is a holiday. Officially, May 29 is our PDUFA date. So we would we assume we could hear on May 29. This is a Memorial Day or we’ll hear the business day before then which would be May 26, if I’m not mistaken, or we would hear the day after May 29. But we’re using May 29 because that is indeed the actual PDUFA date. So I think the question on the payer approach, I think the payer approach, Zolgensma is probably one construct. I think we have an enormous amount of Duchenne-specific experience with the payer community. Obviously, we’ve now been supporting 3 therapies. The earliest approval happened over 6 years ago. So I think we’re in very good shape to have productive dialogue with payers about access and reimbursement for 9001, assuming that we’re able to get approved.
Operator: Our next question comes from the line of Danielle Brill of Raymond James.
Danielle Brill: Doug, I have a question on the micro-dystrophin follow-up data. I believe we saw 60-week data from Part 1 of Study 102. Do you have additional expression data at that time point or any expression data at later time points? And then random question, do you see any legal risk for 9001 from REGENXBIO IP claims?
Doug Ingram: On the second question, I’ll answer and say no, we don’t. On the first question, I’ll turn it over to Louise, if you understand what — I didn’t fully understand the question. Apologies.
Louise Rodino-Klapac: Yes. It was just about additional time points. There’s no additional biopsy time points in the that we have.
Operator: Our next question comes from the line of Hartaj Singh of Oppenheimer.
Hartaj Singh: Congratulations on a very big step forward. Looking forward to many more. Just a question actually on SRP-9003. I know you’ve got the VOYAGENE trial starting the Phase I. You’re doing additional work. Doug, you’re also doing a lot of work around characterizing the material — the clinical material, commercial, et cetera. If you could just talk to that but also just talk to us a little bit about the Phase III design could look like. I believe you’ve indicated that could start later this year.
Doug Ingram: Yes. Louise, do you want to take that?
