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: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Congrats to the recent developments here. So first of all, if I've understood things correctly, looking at the commercialization side here, you've
indicated that that you, in the longer term, could enter an agreement with a larger commercial partner or perhaps several lab partners in the U.s.,
is this correct? And what do you expect you need to get in place before expanding your commercial footprint in the U.S., would it be broader
guideline inclusions or reimbursement coverage? Or what steps should we expect for you to expand that commercial presence in the U.S., if you
will?
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DECEMBER 08, 2020 / 9:00AM, BIOVICb.ST - Q2 2021 Biovica International AB Earnings Call
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Yes, of course. And just as a clarification there. In terms of these lab partners, are they usually keen on getting exclusivity? Or is it a trade-off between
sort of a revenue split, if you will, that they are willing to leave exclusivity open? Do you understand a bit what I'm looking for in terms of their terms
in the agreement, yes?
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Great. And just looking at the case load of COVID-19 cases in the U.S. and the continued rush here for testing applications. Are you seeing any
worries that your 90-days FDA delay could be extended? Or how should we think about that potential risk on the timeline?
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Great. Great. Sounds promising. And just a final question here on the prognostic use case and particularly looking at the abstracts here from the
San Antonio Breast Cancer Symposium. Isn't it usually the case that patient response is poorer in a faster-growing tumor versus a slower growing
tumor, i.e., that TK1 sort of at baseline answers and already clear question in terms of a prediction of outcome in the patients so that, i.e., a higher
TK 1 activity sort of per definition leads to a poorer response? So how should we think about the prognostic use case data?
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Sure. Great. And just final there on the prognostic. Do you think that the prognostic use case will require larger prospective and mortality based
outcome studies to reach guideline inclusion and uptake? Or do you think that other endpoints such as progression and these types of endpoints
are enough, if you will, to gain traction and uptake in that sort of use case?
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: No, basically, just in terms of getting guideline inclusion and broader uptake, if you believe that larger prospective trials, which look at mortality
will be needed to reach guideline inclusion and commercial uptake and they are covered from the insurance companies and so forth?
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Yes, sure.
Question: Rickard Anderkrans - ABG Sundal Collier Introduce - Analyst
: Sure, sure. Right. So that might be a few years from right now?
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DECEMBER 08, 2020 / 9:00AM, BIOVICb.ST - Q2 2021 Biovica International AB Earnings Call
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