Essentially, they referenced the safety and efficacy data generated by UCLA and UCSF and then settlement and completed a bridging PK study to demonstrate their equivalency to those academic products. In direct contrast the two F 18 PSMA agents employed a 505(b)1 recap or an NDA application in which essentially you must demonstrate that you were uniquely different from any other approved agents. The two of 18 approved actions do share a common isotope F 18. And I think as we noted in our comments, it’s well supported with an abundance of scientific literature that F 18 generated images are clearer than those generated by gallium. The two F 18 agents are uniquely different in the PSMA targeting ligand that is attached to the F 18 isotope. And that conveys into important PK and PK differences which we feel are well documented in the reported results of our two pivotal trials.
In both those trials, we reported very high positive predictive value, which, again, as I noted earlier, correlates to low – low positive rates in the trial. So again, I think somewhat ironically, it’d be much more credible to say that the gallium PSMA agents in the US are like, and the F 18 agents in the US are uniquely different. We can go into more scientific discussion of the actual results of trials, but I think those are all well published. The pivotal trials are well published in peer-reviewed journals. And so they are there available for direct comparison.
Yuan Zhi: Got it. Thanks for the clarification. Well, we also heard comments from the other earnings calls that there are adjustments or changes in practice guidelines that do not favor F 18-based PSMA PET agents related to false positive rates, particularly in bone leading — can you clarify if you have seen such changes and we will appreciate any extra color?
Mary Anne Heino: Again, this is one I’m almost going to label as desperately seeking science because in looking at those comments, what we’ve come to appreciate is that the guidelines that are being referenced are the European guidelines. PYLARIFY was just approved in the European Commission, but is not yet included any guidelines. Those guidelines referenced the only PSMA – F 18 PSMA agents that is approved in Europe, which is an agent that is not approved in the US nor under development in the US facility. Why those guidelines would be referenced when you have such outstanding exemplary guidelines in the US with the NCCN, SNMMI and AUA is somewhat bewildering to us. And I will — I tend to confirm to you fully set those guidelines, the US-based guidelines from those exuberate agencies have not changed their stance on PYLARIFY and its value in being used in PSMA PET imaging and in patient selection for PSMA-based therapeutics.
Operator: Thank you. And for your next question. It comes from the line of Anthony Petrone from Mizuho Americas. Anthony, your line is open. Please ask your question.
Mary Anne Heino: Good morning, Anthony. Anthony?
Operator: Once again, Anthony Petrone from Mizuho Americas. Your line is open. Please ask your question.
Mary Anne Heino: Kyle, why don’t we move forward and we can come back to Anthony?
Operator: Yes, sure. No worries. One moment for your next question. And your next question comes from the line of Richard Newitter from Truist Securities. Your line is open.
Richard Newitter: Hi. Thanks for taking the questions. So I wanted to maybe just start off on PYLARIFY. Any color that you can give on how sales and performance tracked throughout the quarter and maybe even into the early part of 3Q? And specifically, did you see any changes or do you see the new competitor — the new F competitor show up at all later in the Q2?
Paul Blanchfield: Thanks for the question. I think we’re confident in the trajectory that we saw over the course of the second quarter, which was in line with our overall expectations. As Bob had noted in the last quarter, we do see impacts from the holidays. So in the second quarter, it would be Memorial Day. We see natural impacts than we would expect over July 4 and then the future Labor Day, Thanksgiving and Christmas. But overall, we’re very comfortable with the trends we saw. We’re not going to comment on what we’ve seen in the third quarter to date, other than Bob reiterating the guidance and raising what we saw and expect in the second half of the year. So overall, we remain confident. As I said earlier in my prepared remarks, we expected an additional competitor to come on board.
