Zevra Therapeutics, Inc. (NASDAQ:ZVRA) Q2 2023 Earnings Call Transcript

Christal Mickle: So it really boils down to — we had our FDA meeting very recently, and so it’s a refinement of making sure that we present the data in a way that the FDA would like to see it. And so with that, there are a few additional analyses. There’s refinement in the way that we’re presenting our arguments and our data. So even though what we’re planning to present hasn’t changed, there is some nuances there that we are going to look at. And so that pushes that a little bit out from that end of Q3 that we had originally talked about.

Oren Livnat: Okay. And I guess to characterize this meeting as, I think, collaborative or productive or both, which is great. I think in the past, maybe — I don’t know if it’s in response to questions or if you volunteered upfront, you talked about, if necessary, you could take, I guess, less collaborative or more aggressive approach with dispute resolution and things like that, if necessary, is — am I detecting a change in tone here because of that was mentioned or in the deck, I don’t think that you feel actually more optimistic now, maybe after your meeting with the FDA, then than you did before and that you don’t think you’re going to have to pursue anything like that? And do you expect to request an ADCOM sort of upfront?

Christal Mickle: So to answer your first question, those options are always still available and still on the table. We do — we were hopeful with this meeting that we had because it was a collaborative meeting, we were appreciative of the tone that the FDA had. And so they do seem to be working with us to get this resubmission in. And then as far as — what was your second point there or your last point?

Oren Livnat: Whether you expect, I guess, upfront to request an FDA, an ADCOM meeting…

Christal Mickle: So that’s an interesting question. I don’t think we will as for upfront. We welcome it if it comes from the FDA, and that’s still a consideration if the FDA does not ask for it that we may ask for it ourselves, but it’s not something that we’ll ask for immediately upon resubmission.

Oren Livnat: Okay. And if I just may look a little further down the line, assuming this all goes well. Any progress that [indiscernible] talking about on remarkable life cycle management. I think there was some hopes to improve dosing, get some more additional IP around the project? Anything to report there?

Christal Mickle: So right now, we are focused on approval. But those are always things that we will look for as we move forward.

Operator: [Operator Instructions] Our next question comes from Sumant Kulkarni with Canaccord.

Sumant Kulkarni: I have a couple. So on the lease commitment of the arimoclomol NDA, you mentioned the productive and collaborative process with the FDA, which portion of the 3 parts of the Complete Response Letter and your ongoing response. Would you say that the majority of your last interaction with the FDA was focused on? And then I have a follow-up.

Christal Mickle: So we really — we presented everything because we did treat this as a pre-submission meeting, but we have — a large part of it was also focused on the confirmatory evidence that the FDA hasn’t seen in the past.

Sumant Kulkarni: Got it. And then in the last meeting with the FDA, did the agency state specifically that no additional clinical data would be required, or did the FDA making suggestions that additional clinical data that may be required but left to the discussion of Zevra on whether to run those are not prior to these submission?

Christal Mickle: There was no discussion about additional clinical data being needed.

Operator: And our next question comes from Jonathan Aschoff with ROTH MKM.