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.

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.

The FDA keeps telling you, no, no, no, not unless you do these trials. So I don't know in our lifetime, will we get... So are we going to avoid ovarian cancer? Are we going to avoid triple negative breast cancer? Are we going to avoid pancreatic cancer?

The drug Cerolimus, originally for organ transplant rejection, has kept Dr. Fagenbaum in remission for over 11 years.

We've done this with healthy volunteers already. More importantly, the NCI then designated us to treat patients without cancer, i.e. patients with what we call Lynch syndrome.

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 allow my booster as part of the mRNA vaccine regimen, without explaining why.

Dr. Fagenbaum's nonprofit aims to ensure that all FDA-approved drugs are used for every disease they can possibly treat.

We injected this in 8,000. And what kind of response rate have you seen from the people who do have a cancer? Metastatic pancreatic cancer. Patients now alive, still six years.

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.