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: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Thanks. Good evening, and congrats on all the progress. The first question is just on the enrollment completion in the CANOPY Phase 3 trial. Can
you remind us what we need to see in terms of day 28 serum neutralizing titers and at each dose that would give confidence in the VYD222 EUA
submission?
And then just on the EUA submission, a clarification. It sounds like you can submit following the primary endpoint data from Cohort A. Is that
accurate? And separately, what role, if any, would the month three redosing data in Cohort A and data from Cohort B have, in terms of gaining or
maintaining the EUA?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Got it. That's helpful. And then if I could, just a few on the commercial launch and the preparations, follow up on that in greater detail, specifically
with regards to the scale-up and manufacturing and payer discussions. Are there any particular reimbursement codes or other aspects of the launch
that are unique for this type of launch, particularly with regard to payer coverage?
And then, just as it regards slide 8. This is a broad group of patients who could benefit from VYD222. So I'm wondering if you can discuss the
expected launch trajectory? How you're deciding how to manufacture at this stage, and if there's any particular immunocompromised patients
that would be the focus? Or would this be a broader effort for the launch if VYD222 received authorization?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Right. That's great. Thank you very much.
Question: Jenna Li - Jefferies Group LLC - Analyst
: Hi, good evening. This is Jenna on for Mike. Thanks for taking our question. We wanted to get your take. What do you think are the gating factors
for submission, given that 28 days is either really soon or we've actually passed the eight days since the end of Q3?
So how should we think about when you'll be able to put everything together to submit? And then the next step from there, and ultimately, how
confident you are that FDA will approve, just based on titers? Thank you.
Question: Jenna Li - Jefferies Group LLC - Analyst
: Got it. Okay. Thank you.
Question: Maxwell Skor - Morgan Stanley & Co. LLC - Analyst
: Great. Thanks, and congrats on the progress. So in regards to your EUA data package. How often are you required to update your in-vitro neutralization
assay to include currently circulating variants? And also, given the design of your CANOPY trial, would you expect to be authorized in both the pre-
and post-exposure setting? Thank you.
Question: Maxwell Skor - Morgan Stanley & Co. LLC - Analyst
: Great. Thanks.
Question: Evan Wang - Guggenheim Securities, LLC - Analyst
: Great. I had a follow-up in terms of some of the pre-commercial planning ongoing. Can you provide a sense of, at least, initial thoughts on the size
of the sales force needed for that targeted population approach?
Question: Evan Wang - Guggenheim Securities, LLC - Analyst
: Great. And then in terms of some of the pre-commercial manufacturing ramp. Can you provide us any color in terms of some estimates or how
extensively you plan to sell that inventory? Then I have a two more follow ups.
Question: Evan Wang - Guggenheim Securities, LLC - Analyst
: Got it. And in terms of some of the Phase 1 data, I think you guys are tracking that over time. So just wondering how the chemics are looking over
there? And if there's any implications or thoughts on, I guess, how redosing could look in the future?
Question: Evan Wang - Guggenheim Securities, LLC - Analyst
: Got it. And then last one for me. It's great to see all the market research. Just wondering how, I guess, payers, KOLs are looking at -- how much do
they value clinical data versus the surrogate? Is there acceptance of this surrogate beyond FDA? Thanks.
Question: Evan Wang - Guggenheim Securities, LLC - Analyst
: Great. Thank you.
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