Unknown Analyst

All right. Let's kick off our next session. Good morning, everyone. I am very excited to host Celcuity. And with me is Brian Sullivan, CEO and Co-Founder of the company. We have a lot to go do a lot happening in the company. But before we get there, I'm going to turn it to you for opening remarks.

Brian Sullivan
Co-Founder, Chairman & CEO

Sure. So I guess the most important thing to understand about Celcuity is that we're focused on treating diseases that involve the PI3K/AKT/mTOR pathway, which we refer to as the PAM pathway. Our lead candidate is a multi-target inhibitor of that pathway, and it's able to comprehensively shut it down. And the pathway itself represents probably one of the most important oncogenic pathways overall, but also one of the most challenging drug. And the real advance that gedatolisib has demonstrated so far, and I'm sure we'll get into that, is the superior efficacy and better tolerability you can achieve with the approach that it takes relative to the approved drugs in this class that have essentially narrowly targeted the inhibitor rather this pathway in a less efficacious way.

Unknown Analyst

Fantastic. So the FDA granted priority review and you guys have a PDUFA date coming up very soon in that wild-type population. How is the commercial prep going for that? And how -- what does it take?

Brian Sullivan
Co-Founder, Chairman & CEO

Sure. So you're referring to our Phase III study in second-line breast cancer, where essentially we evaluated patients who HER2 -- HR+HER2-negative advanced breast cancer, [indiscernible] PIK3CA mutations. So fantastic results, really unprecedented results. And we've anticipated success in this