Zogenix, Inc. (NASDAQ:ZGNX) Q3 2019 Earnings Conference Call - Final Transcript

Nov 07, 2019 • 04:30 pm ET

Previous

Zogenix, Inc. (NASDAQ:ZGNX) Q3 2019 Earnings Conference Call - Final Transcript

Share
Close

Loading Event

Loading Transcript

Q & A
Operator
Operator

[Operator Instructions] Your first question comes from Paul Matteis with Stifel.

Analyst
Paul Matteis

Congrats on the progress. I was wondering if there's anything you can tell us about the EMA review and whether or not there have been any surprises and whether or not you've discussed the preclinical animal model conversation that came up with the FDA in the RTF. And then just a couple other quick other ones. I was wondering if you've given any additional FINTEPLA long-term safety data at EMA and if you could comment on that and whether or not it's aligned with last year's AES presentations. And then lastly I just have one follow-up but I'll stop talking for a second.

Executive
Stephen J. Farr

Paul thanks for your questions. With respect to our interactions with EMA we have received our day 120 questions and we're working towards getting our responses to the reviewers by the end of this year. With respect to the questions that we received they were right across the gamut of the sections of the submission clinical and nonclinical and CMC and nothing that was pertained to us having to generate more data. So really nothing surprising I would say in our interactions to date. Gail anything you'd like to add to that?

Executive
Gail M. Farfel

Only that the data that we presented to the EMA with regard to your question about long-term safety it's the same set that we have talked about I believe that AES has provided to the FDA.

Executive
Stephen J. Farr

And Paul just again on the long-term safety we will move forward with an analysis of our open-label extension data to satisfy the day 120 safety requirements. So that will be a larger data set with more patients and obviously with longer durations of exposure and we'll be probably reporting that publicly once it's been submitted to the FDA.

Analyst
Paul Matteis

Okay. Okay. And then on the IST is that something we could see some data from next year? How many patients do you think might be in that? I'm referring to the study in Doose and TSC?

Executive
Stephen J. Farr

Go ahead Gail.

Executive
Gail M. Farfel

So that is a company-sponsored trial. And we're -- also we're enrolling across 7 different indications. And the indications will be analyzed individually. So our hope is that we get enough patients in at least 1 of the 7 indications if not more to be able to give an analysis of one or more of the indications late in 2020.

Operator
Operator

Your next question comes from Marc Goodman with SVB Leerink.

Analyst
Marc Goodman

So first of all can you talk about the CBD trial that you presented at the meeting just recently and what type of feedback you got from the physicians? Do they feel like they understand how to use the products together? You mentioned something about having to adjust dosing. What exactly do you think are the learnings that we've got there? That's number one. And then second of all you talked about commercial preparations but would you mind just going through again where we are and what exactly you've done