Novavax, Inc. (NASDAQ:NVAX) Q4 2023 Earnings Call Transcript

John Trizzino: Yes. Yes, so the BLA pathway is, what we’re pursuing at the moment. But as you stated, there is an availability for EUA if that’s needed. Given timing, the most significant piece of the strategy here is to be on time for market. So whether that be under EUA or BLA will allow us to be present in front of the vaccination season, allow us to bring our pre-filter into the market for the convenience of the healthcare providers. And so I think those elements are the most significant piece. We do have a lot of work that’s being conducted between our regulatory teams and our CMC teams with CBER to ensure that there’s a sharing of information under this rolling submission. The intent of the rolling submission is to get them as much information as early as possible to streamline their review process.

Can’t comment upon kind of regulatory timing, but we’re making significant headway in making that possible for the fall season. So look, we’re confident in the data that we’re providing, we’re confident in that process, and we’re confident in the data that we have so far to deliver against those three objectives.

Alec Stranahan: Thank you, John.

Operator: Thank you. There are no further questions at this time. I will now turn the call over to Mr. John Jacob. Thank you. Please proceed.

John Jacobs: Thank you everyone for joining us today. We wish you a great close to your week.

Operator: Thank you. That does conclude our conference for today. Thank you all for participating. You may all disconnect.