Savara Inc. (NASDAQ:SVRA) Q2 2020 Earnings Conference Call - Final Transcript
Aug 06, 2020 • 04:30 pm ET
Thank you. We will now begin the question-and-answer session. [Operator Instructions] First question is from Michael Higgins from Ladenburg Thalmann, Please go ahead.
Good afternoon, guys. This is Edward on for Michael. I appreciate you taking the questions and congrats on finalizing the design from IMPALA 2, just a couple questions on the design. I'm wondering you talked about 20 sites opening up in the US and Canada. I heard that correctly.
So just wondering how many you expect to be spread through the EU and Asia? And then in terms of the timing for releasing of the data, or the data itself, I'm just wondering with the EMA or the FDA will require the full 24-week or the full 48- week data before you are allowed start to put together something like an NDA.
Our size in U.S. and Canada will be 2020 approximately. The total number is size is approximately 15. And the spread, we'll have about eight or nine countries in the EU. And also some sites in Japan and Korea. The spread will be more or less even across the EU and Japan and Korea.
So exactly global scale oxides. As far as the 24-weeks versus 48-weeks for the submission of an application to the FDA or the EMA. The 48-weeks is the placebo controlled time period so if mission will happen to the read out of the 48-weeks back.
Okay. Thank you for clarifying. And in terms of the aPAP asset. I'm wondering if when you anticipate having those FTA discussions and whether they be impacted by COVID. And you anticipate running this trial in tandem with IMPALA 2 or would you prefer to wait until you get that data come in?
Let me answer that one. This is Rob. So we haven't guided yet. But our internal goal is to have those discussions with the FDA deployment as soon as feasible. Hopefully this year, if not early next year.
And then as far as running the study in parallel, yes, we believe we will do those in parallel. Once that study is up and - once the study design has been set. And we have done only internal planning from a clinical operations standpoint, they will most likely be an overlap.
Okay, perfect. I appreciate all the detail. Thanks and congrats again.
Thanks. Good questions.
[Operator Instructions]. There are no more questions in the queue. I will now hand the call over to Anne Erickson to read any questions submitted through e-mail.
Thanks. We've got one question submitted, So one concern is involved with the positive impact whole lung lavage had on the AA ingredient. Is that also the case with DLCO?
I'm going to take this question. We have said that [Indecipherable] still benefit a patient even after undergoing a whole lung lavage. Contract the general belief that whole lung lavage improves gas transfer. Such an effect was not shown in the IMPALA study. Perhaps it is due to the lack disease severity of