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.

We do know now that if we catch the cancer early enough, even if you fail chemo, you fail radiation, brain tumors, we now have patients with brain tumors who have failed everything, come to see us. We're getting almost a complete response.

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.

I said to these two reviewers, senior reviewers, one a female and one a male, they've been here for years and years. If my father had bladder, Why wouldn't I give my father that chance? Response? I don't care.

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!

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.

We have a trial now going on with long COVID where we're giving this BioShield for patients with long COVID. It's open.

If you go to csfifm.org or .com, you will see the trials that I'm now open as randomized trials. So we're now taking patients with lung cancer who failed in.