A – Pascal Soriot: Thank you, Andy. And we’ll start with an online question by Andrew Baum. Andrew, go ahead.
Andrew Baum: And apologies for the background noise. First question in relation to risk and this is an observation rather than a criticism. You’re expediting a number of particular oncology programs into Phase III from Phase I. Obviously, you’ve been involved in by some of your peer experiences with data DXD and low HER2, for example. But how do you think about managing that risk in the balance of return within the overall portfolio? And then second question in relation to your prophylactic COVID-19 antibodies. Do you hope to get approval under EUA or this full approval? And does that impact how you’re able to use your field force to promote the drug. I note there’s a significant uptick in the fourth quarter prior to the removal of the EUA. So I care about this from an ongoing revenue perspective.
Pascal Soriot: Thanks, Andrew. So maybe Susan, you can cover the first question. And Iskra, you’ll cover the second one which is a pro and use of field for.
Susan Galbraith: Okay. Thanks for the question. So I think in terms of the acceleration of products from early phase into late phase, we do have efficacy expansions in all of the trials where we’ve moved products into late-phase decision-making. So we have a robust dose selection data sets and we have robust both efficacy and safety data sets to support those investments. And in the case of the ADCs we’ve got a clinically validated linker warhead combination. And based on the data we’ve already seen within HER2 which together with the data that we have, with datopotamab deruxtecan across multiple trials gives us confidence in the profile. And similarly, with the bispecifics, I would just comment that I think CTLA-4 is a very well-validated target.
The challenge has been the tolerability and the design of a Rustenberg is designed to address specifically that challenge and we’re encouraged by the data that we’ve seen, particularly with longer follow-up to support that. So I feel that we’re not just accelerating them. We’re accelerating on the base of good data that convinces us that this is a good balanced risk.
Iskra Reic: Yes. So thanks, Andrew, for the question. As you fairly noticed, we are definitely advancing the development of our new antibody and we do aim to make it available to the patient in the second half of this year. Obviously, while developing the clinical development program, we also consulted with the regulators, including FDA, — and there is an agreement to basically look at the immunobridging data from the study and the grant emergency approval based on those data. And the key reason for that is the significant unmet need and this long-acting monoclonal antibody the same as the shale they remain the only option at a given time for the protection for immunocompromised patients. On your second part of the question on the promotion, that is absolutely correct that any emergency approval dictate how much you can do and the promotion with the Fiore in U.S. But it’s also important to note that during the care because of the high unmet need, there were different exceptions because all stakeholders do understand the importance of education and raising awareness, both in a patient population that needs protection as well as with the health care product professionals.
And we do believe that, that will continue, again, given the high unmet need and given the fact that COVID is here to stay and those patients will need protection going forward.
