Steve Fruchtman: Sure. And Meena, as our RDEB squamous cell expert and expert in rare diseases, would you like to take that question of how we introduced the concept of RDEB squamous cell to the orphan group at FDA? Meena? Meena’s calling in from the U.K. Perhaps she was – the connection was lost. So I’ll take that. If I may. I think the goal – this is clearly an orphan disease, right? There are 60 to 100 patients per year that develop RDEB in the U.S. Once squamous cell develops, the patients, 50% of the patients die within 2.5 years. So clearly this is an orphan disease. Our goal at the orphan group is to explain to FDA why this is different than what I’ll call spontaneous squamous cell. For instance, sun damaged squamous cell.
And it’s different because one, RDEB squamous cell develops in late teenage years, early 20s. Sun damaged squamous cell develops in the elderly. Sun damaged squamous cell has a very good prognosis. Usually they move surgically and that’s the end of the therapy required. RDEB squamous cell is a very aggressive disease as I just mentioned. And the cynical known that differentiates spontaneous squamous cell from RDEB squamous cell is the fact that squamous cell complicating RDEB has a mutation of the collagen 7 gene which spontaneous squamous cell does not have. So our goal at the orphan group is to explain why this disease, RDEB squamous cell is different in common squamous cell which in fact is not by their definition an orphan disease but clearly RDEB squamous cell is and our goal is to interact with the agency to explain in greater detail what I just said.
Meena Arora: Apologies, my line dropped. Thank you for answering that. I’ve got no further things to add apart from we have, hello – we’ve also presented last month at the EADB meeting as a late breaking abstract and we’ll be taking learnings from the initial patient experience and moving that into the clinical development registrational program as well and into discussion. So in addition to the discussion we’ve mentioned about the orphan group designation, we’ll be also doing that. Apologies, my line dropped there.
Steve Fruchtman: Thank you very much. [indiscernible].
Meena Arora: Okay.
James Molloy: Thank you very much. I guess the one follow up question would be, is it more sort of a check various boxes or do you have to go make a presentation and sort of pitch them on the disease or is it just kind of a form to fill out? How does that sort of mechanically work?
Steve Fruchtman: We’ll basically do it anyway the orphan drug designation group wants us to and hopefully there will be a chance for an interaction with them. We think that’s much more valuable. The FDA orphan group will make that call. We will request a face to face meeting. My understanding is they’re doing most of these virtually and they may just respond to a written briefing book on why we believe we deserve orphan designation.
James Molloy: Thank you for taking the questions.
Operator: I’m showing no further questions in the queue. Ladies and gentlemen, thank you for your participation on today’s conference call. This concludes today’s event. You may now disconnect.
Steve Fruchtman: Thank you.
