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Why The FDA Would Be Foolish Not To Award PV-10 Breakthrough Therapy Designation

|Includes:Provectus Biopharmaceuticals, Inc. (PVCT)

EXECUTIVE SUMMARY

I think it is very likely that FDA approves Breakthrough Therapy Designation (BTD) for PV-10 in some indication of melanoma... but you need to why I come to this conclusion so that you can decide for yourself.

UNDERLYING DATA

But my guess, and it is only what I'd call an educated guess... can't be based upon a comprehensive study of past awards and rejections (as I'd like) because we don't have all that data in the public domain. We don't know what materials were supplied to the FDA by each sponsor, so we can't compare that to what Provectus supplied. We don't even know most of the drugs that had applications filed because most companies are too afraid to announce an application for BTD.

We just don't have those details, so the decision is more difficult.

We do have a recent case of a BTD approval, for Clovis, a few days ago. Clovis had a slightly smaller number of appropriately treated patient than Provectus "all tumors treated" group. Clovis had good results, but not as good as PV-10, results... and it was granted BTD. The Clovis drug that got BTD approval is not very toxic as cancer drugs go, but it has more side-effects and more serious side-effects than PV-10.

The Clovis decision supports my view that the FDA will approve BTD for melanoma for PV-10, but my reasoning doesn't rely on the Clovis example.

I will explain the rest of the reasoning that requires I make that decision, but I am going to do so, only after I make the point that, giving you this information, gives me no benefit, and it exposes me to be wrong... something analysts and pundits prefer not to do, as a general rule. I could just wait until after the decision and say, I told you so, even if I didn't.

Since I am more than willing to admit than I am not infallible, I therefore prefer to explain my reasons to you and ask YOU to consider my reasons and reasoning as more important than my "guesstimate".

In other words I WANT YOU TO CONSIDER THE EVIDENCE AND MAKE YOUR OWN DECISION.

WHY THE FDA SHOULD GRANT BTD To PV-10 for MELANOMA

To get BTD a drug is supposed to be

1. for a life-threatening condition and

2. more effective than the existing treatment.

Melanoma is deadly and the data indicate that PV-10 works better than the competition... as proved by the patients in the Phase II trials. These people, on average, failed a median of 6 other treatments before they got treated by PV-10. And PV-10 worked (had an observable tumor response) for 71% of them.

In the recent work by the Moffitt Cancer Center (to be fully presented at ASCO in about 10 days) 50% of the patients, also people who were not helped by a bunch of other treatments, had a COMPLETE RESPONSE... meaning their TUMORS actually DISAPPEARED. And there were very sick people, with terminal cases of melanoma.

So we know PV-10 works for melanoma.

It works better than currently available drugs.

And melanoma is a serious condition, killing about 10,000 Americans each year.

The criteria for the award of BTD are satisfied.

THE KICKER: SAFETY

We also know that PV-10 has no significant systemic side effects.

PV-10 will not kill a patient, even if the person is old and weak and has a compromised immune system. PV-10 doesn't make patients weak and nauseous, make their hair fall out, make them pass out, interfere with their ability to keep food down, or ruin their blood count, or damage their liver or kidneys, like some other cancer treatments.

It is also likely to cost $30,000 per patient or less to treat melanoma, compared to competitor Yervoy, which costs $90,000.

The safety of PV-10 has been established by almost 100 years of being used in people's eyes or livers as a diagnostic aid.

The drug safety issue with PV-10 makes approving PV-10 a no-risk, no-brainer decision for the FDA. If the FDA BTD Committee believes that more data needs to be collected, the FDA would know, in advance, that NO PATIENTS WOULD DIE SOONER because they were treated with PV-10.

First, because the drug is safe.

Second because scientists at the Moffitt Cancer Center have recently demonstrated that melanoma cells are effectively gone within 7 to 14 days after getting a shot of PV-10 into the tumor... in patients who had tried many other treatments; treatments that did not work.

The FDA knows (unlike some investors) that approval of BTD is not the same thing as approval of an NDA. It does not automatically allow everyone to be treated with PV-10 indiscriminately. Approve of BTD status for PV-10 just speeds PV-10's progress towards a NDA filing with the FDA for final approval.

Therefore, the only logical action on the part of the FDA, as I see it, is to approve BTD for PV-10. If the FDA BTD Committee thinks it would be smart to collect more data, they can have Provectus do that, before or after NDA submission. Provectus, to get approval in Europe, Australia, China, etc. is going to run at least a short trial in those countries, anyway. It is not a big deal, nor expensive, given that treated tumors shrink and can disappear in less than 1 month.

THE DYNAMICS OF DECISION MAKING MAKE FDA PRONE TO APPROVE

Decision makers, like an FDA Committee, dislike making decisions where a false positive reflects badly on the decision-makers, for example where they may lose their job or be demoted for being wrong. An example of a false-positive decision in the current context is when the FDA approves a drug that then kills people instead of helping them.

In the situation I am writing about, approving PV-10, a false positive decision kills nobody and only postpones other treatment for a week or two.

Saying "yes" to BTD for PV-10 in melanoma is probably the least risky decision the FDA BTD Committee can make all year. And if PV-10 fulfills its promise to make all solid tumors shrink and/or disappear, the FDA people who were instrumental is speeding this drug to market for the first of many indications will save thousands, actually millions, of lives by their action.

As yourself what action would you take if you were on the FDA Committee and had this opportunity to help so many cancer sufferers and their families, with no significant risk attached.

Would you reject it, slowing its progress?

You decide...because the FDA is apparently about to do so. They will transmit their decision to Provectus any day.

Disclosure: I am long PVCT.

Additional disclosure: I have added to my position during the buying opportunity, this week.

Stocks: PVCT