PortalsOS

I visited the FDA to ask, you've approved this drug for bladder cancer. You have in the package insert the mechanism of action. It's the only drug in the history of medicine, which is basically your natural protein.

Sometimes we just need an AI grandma to give us old school, warm, blunt, and human advice. So I think that there's an opportunity to build like a life advisor and you build a brand around like an 85-year-old woman who like bakes apple pies.

Three weeks later, I see in the press that Johnson & Johnson is about to get priority review by the agency for chemotherapy in the bladder.

It's incongruous to me that you can priority review for chemotherapy and not priority review for a biologic that is safe.

The FDA refused to file our data for bladder cancer treatment, even though we have patients alive and cancer-free for 10 years. It's mystifying!

The review process took two and a half years. It just got approved. This is why I said this president, and you and I talked about it, in his presidency could inform the world and the FDA that there's a breakthrough for all tumor types.