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Mea Culpa: The FDA And I Have Different Assumptions

|Includes:Provectus Biopharmaceuticals, Inc. (PVCT)

PROVECTUS AND THE FDA BTD APPLICATION

The rejection of the application for Breakthrough Therapy (BTD) designation for PV-10 is tragic for the people suffering from cancer that will die waiting longer for a drug that works well without nasty side effects. And it is certainly negative for those of us with large investments in Provectus, although it is likely only a postponement of our profit.

The FDA acknowledged "the reduction in the size in one to 10 target lesions in patients with locally advanced melanoma, who may have additional untreated cutaneous, subcutaneous, or visceral sites of disease."

They indicated "clinical data provided in your request for Breakthrough Therapy designation are indicative of drug activity in the treatment of local, satellite or in-transit recurrence of malignant melanoma".

This means that the FDA acknowledges that PV-10 worked and that it reduced or eliminated from 1 to 10 melanoma lesions per patient.
I reiterate, these quotes from the FDA Letter means the FDA said the drug worked, people.

REGRETTABLY

They also said they were not granting BTD because eliminating tumors is not the kind of data they think relevant for "locally advanced cutaneous melanoma."

Seems relevant to me and I bet it seems relevant to most of you, but it was not related to the "clinical benefit" of the drug, as defined by the FDA. I think the FDA was wrong, but I am not an MD and I don't work for the FDA. It is up to them, not to me, obviously.

I based my expectations on the assumption that the FDA would be overjoyed to see a 71% Observed Tumor Response rate.,,and that this significant a Tumor-Response was better than competitors.
That is why I was mistaken.

I regret if what I considered my logical assumptions misled you. As I said in my prior article on the FDA decision, I know I am not infallible and that's why I explain my reasoning and not just provide people with a judgment.

I hope to have more to say about what comes next, once I have the chance to study the situation and talk to the company. My view is that we may see an acceleration of the Liver Cancer trials. There are many more liver cancer sufferers because other cancers very commonly metastasize to the liver. It is often the liver cancer and not that original cancer that kills. With treating liver cancer, there are more people to help and much more revenue for Provectus or whoever buys the company.

 

With this FDA disappointment, it seems important to keep in mind that PV-10 kills cancer and stimulates patients' immune systems to kill cancer.

 

Disclosure: I am long PVCT.

Stocks: PVCT