The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: This is Jakob Lembke at ABG. I have a couple of questions. And my first question is on the development towards getting the 510 clearance. Maybe
you can just sort of elaborate a bit more on what sort of additional data you have to complement your application with?
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: Yes. Yes. I follow. And my second question...
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: Understood. Then my second question also on the FDA. Is sort of your impression of how the FDA is transitioning to a sort of post-pandemic state
is sort of the degree of uncertainty regarding the time line and review times and so on are improving?
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MARCH 15, 2022 / 2:00PM, BIOVICb.ST - Q3 2022 Biovica International AB Earnings Call
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: Okay. And if we move on to your new sort of U.S. go-to-market strategy, obviously, I mean, it's a good opportunity to be able to have a direct
interaction with the clinicians, but I'm wondering a bit on your view of sort of your ability to reach the broader market and how this new strategy
will impact sort of sales ramp-up, if maybe the sort of penetration development will be a bit slower with this strategy?
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: Okay. And just a follow-up on that. I mean, with the, let's call it, evolved strategy then and also the establishment of the CLIA lab, how will this
impact sort of the near and midterm costs, think of all, let's say, rents and maybe also increase of head count?
Question: Jakob Lembke - ABG Sundal Collier Introduce - Analyst
: Understood. And my final question, just Warren, you mentioned that you had previous experience from working with lab-developed tests. And I
guess that is dependent on having a CLIA lab. So just going forward once you have that, is a lab-developed test a potential route you're going to
explore as well?
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