Quote:

---

Didn't we match up similarly to SOC in mTNBC with a better safety profile?

---

We initially published results vs. the previous standard of care and blew right past that. The FDA wasn't happy with that because Trodelvy was the newest standard of care. Trodelvy's median overall survival was 11.8 months. Leronlimabs mOS was 12+ months. Most likely we couldn't tell the FDA exactly how long the mOS was because Amarex was holding the data hostage. The FDA wouldn't take it seriously until we knew. Of course now we have the data. I'm impatiently waiting for that paper because even a 25% increase would be an outstanding result.

As far as the safety profile goes, Some of Trodelvy's side effects can be life threatening. A far cry from our safety profile.