Brian Abrahams: Good morning. Thanks for taking my question. Congrats on all the progress and appreciate all the details. Maybe just another clarification on 8 milligram aflibercept. Can you characterize your level of confidence that a re-inspection would not be required? Have you had any interactions or feedback with the agency around this? And is there a defined period of time where the FDA would need to wait re-inspection or not to ensure that the remediations are sustainable before proving to BLAs? Thanks.
Leonard Schleifer: Great. Thanks for your question. Look, we’ve tried to be 1,000% transparent as usual Regeneron. And this is really, let me just see if I can summarize it, again, what we know. We’ve been in close contact with the FDA as has Catalent. We know what the remediations required are and we’ve been submitting them on a rolling basis. We expect to submit the last requirement by the middle of August and that will be several days before the PDUFA date for the pozelimab BLA. The FDA has been very clear that they will strive to expeditiously review that. If they can, great. They can’t, they said there would be a three-month clock extension. But even with a three-month clock extension, they’ve been very categorical in saying that they would prioritize our review and try and get it done as soon as possible.
Those facts are what led us to believe it would be done during the third quarter. In all of this, is the fact that there has been no need, no discussion, no indication whatsoever that a re-inspection would be necessary. The FDA of course is free to make those decisions, but we have not seen any indication of that in our very detailed and close contact. So we’ve given you our best estimate at this point.
Ryan Crowe: Thanks, Len. Let’s move to the next question, please.
Operator: Our next question comes from the line of Chris Schott with JPMorgan. Your line is now open.
Chris Schott: Great. Thanks so much. Can you just come back to the CD28 PSMA update? Maybe just elaborate a little bit more in terms of the approach of lowering the PD-1 exposure to address the safety issues here and taking that approach versus trying to work to further adjust the dosing of the bispecific piece of the equation? Thanks so much.
George Yancopoulos: Well, we should say that we are adjusting both doses. We have been already exploring a variety of doses from very low doses to the highest active doses on the costim side. But we’ve been doing all of them in the context of the full dose Libtayo. So now what we’re doing is we’re exploring some of the doses that are active, particularly ones are active as monotherapy, as I mentioned, there is monotherapy activity with the PSMA costim. And now we are — to try to decrease these immune-related adverse events. Let me remind you, they are on the same sort of class of immune-related adverse events that you do see with checkpoint inhibitors in general. We’re just seeing them in some patients, the one with the biggest responses in some cases to a greater extent.
So we’re hoping that lowering the checkpoint inhibition may allow us to adjust the therapeutic window there. But we are as you are saying dealing with a couple different doses of the costim, but now we’re incorporating lower doses of the Libtayo into the program as well.
Leonard Schleifer: I think what George said earlier, just maybe it bears repeating, is that he said that we’re starting with the good position of having very impressive efficacy, one. And two side effects that for the most part in the patients who are benefiting with the efficacy, that’s a very good position to begin to explore and how to get the therapeutic index or signal to noise as George calls it right.
Ryan Crowe: Okay. Let’s move to the next question, Shannon. Thank you.
Operator: Our next question comes from the line of Dane Leone with Raymond James. Your line is now open.
Dane Leone: Hi. Thank you for taking the questions. Congratulations on the updates and best of luck with the resolution of the reviews for pozelimab and 8 mg aflibercept. I actually want to ask you to expand a bit on your discussions with the FDA and potential filing or early filing on Dupixent for COPD. The point I’d like a little bit more clarity on specifically what you may be able to have from NOTUS before the final readout of that study that you could potentially include in a package with the BOREAS results to get the FDA comfortable with an accelerated review for that indication. Thank you.
George Yancopoulos: Yeah. What we know right now is that we’re going to need data from NOTUS. And right now, as we said, we are still in discussions on what that data could be. And so right now, we don’t have any details to give you.
Ryan Crowe: Okay. Thanks, George. Hopefully an update and next question, please.
Operator: Our next question comes from the line of Colin Bristow with UBS. Your line is now open.
Colin Bristow: Hey, good morning, and congrats on the quarter and the progress. Just maybe one on the itepekimab interim. Can you share anything on the utility threshold? And if not, specifically, could you say how the sort of Fed relative to BOREAS? Thanks.
Leonard Schleifer: I don’t think we have anything specific. This was handled by the Data Safety Monitoring Committee sort of a standard approach. We’re pleased that we passed it. And we will look forward to further data at the end of the study.
Ryan Crowe: And both we and Sanofi are blinded to that. We only got the go-decision from the Independent Data Monitoring Committee. So we will proceed to a final readout for both of those studies. Let’s go to the next question, please.
