This is the daraxonrasib news I’ve been refreshing the RevMed site for! The NDA has been accepted for FDA review. And before anyone says it: no, this is not “late.” NDA packets are enormous. Clinical data, CMC, safety, labeling, subgroup analyses, QA, regulatory back-and-forth. It takes time to package a drug for FDA review, especially when the goal is not “nice phase 1 signal” but actual approval. Now the timer starts. ⏱️ Why does this matter? An oral RAS inhibitor with phase 3 PFS and OS benefit is a big deal. I think we've all said that enough by now. Now the FDA gets to do what it has said it wants to do: Get life-saving drugs into patients’ hands as quickly as possible (outside of an EAP program). FDA clock officially started. ⏱️ @TheGutOncLab @OncoAlert @oncodaily @Onco_Nexus