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Re: cfoofme post# 2077

Tuesday, 08/28/2012 11:14:04 AM

Tuesday, August 28, 2012 11:14:04 AM

Post# of 2096
L vus Monday, August 27, 2012 7:53:40 PM
Re: None Post # of 62368

Cox has followed up with another article:

Fortunately, there's plenty of news for me to share that has importance far past these next few days. In fact, the two items in the headline will have obvious and measurable impacts on national and international health and longevity statistics. These impacts are also the basis for enormous financial value.

Some cost estimates of normal seasonal influenza in the U.S., both direct and indirect, range as high as $150 billion annually. If it's only half that, which is clearly too low, it is still a significant drag on economic growth and the good things that come with it.The economic impact of a true pandemic in America would be at least twice that. The cost in Europe would be about twice the American costs. Internationally, the total impact of an influenza pandemic would easily move into the trillions of dollars.

Let's look at a normal year, however. Typically, about 35 million people get the flu yearly in the United States. This number applies even in those years when flu vaccines have hit their mark and are capable of preventing influenza. Vaccination will never be widely adopted.

The cost of a course of Tamiflu, which is largely ineffective, runs about $80. When we believed that the NanoViricides flu drug would have to be delivered via injection, it was very difficult to project its use. Now, however, we know that these polymer/ligand constructs can survive the stomach and be delivered orally. For that reason, I think that it is entirely reasonable to assume that 30 million people would take a treatment for a dangerous flu that would end symptoms in just an hour or two -- every year. Insurance companies would pay for the vast majority of uses.

So $100 times 30 million uses is $3 billion a year. Double that for the European market and double it again for the world and you have potential sales easily exceeding $10 billion annually. Remember, this is an extremely inexpensive drug to manufacture when scaled up, so most of that revenue would fall into the profits column. When a pandemic hits, you would double sales… at least.

The reason I say "at least” is that an orally deliverable drug would work for flu prophylaxis, or prevention. Remember, nanoviricides are big molecules compared with small molecule proteins. They are not metabolized and persist in the blood system for an extremely long time, perhaps months. This means that many people who are not at high risk for the flu would probably take the drug as soon as a pandemic hit anyway.

Interestingly, it would not prevent infection by the virus. This is a feature, however, not a bug. When the virus is contracted by someone with nanoviricides in their system, very low-level infection occurs in at least a few lung cells. This is all the immune system needs to create a lasting immunity. NanoViricides' flu drug would, therefore, facilitate a kind of natural inoculation, allowing huge populations to develop immunities to otherwise life-threatening viruses without ever getting sick.

If I could provide a soundtrack with this letter, you'd hear a chorus of angels singing now. Seriously, this drug has the potential to change world history and accelerate global progress measurably. That, however, is only the beginning.

Now that we know that nanoviricides for influenza can be delivered orally, the odds are that an HIV ligand that can survive will also be identified. That would be the end of AIDS as we know it, which would lift Africa out of the dark ages. Global domestic product would be kicked up a notch, which would benefit everybody by increasing trade and wealth internationally.

Also likely targets for oral drugs are herpes, Ebola, dengue, etc. In fact, all viruses now are threatened by oral drugs, even more-obscure viruses like human papillomavirus and the deadly hantaviruses. I hear angels singing again, accompanied by the sound of cash register bells.

Allow me to explain the ligand comment I made earlier. Some of you may notice that the press release announcing the oral drug put mouse survival at 347 hours, or 14.5 days. Previous NanoViricides tests of an influenza nanoviricide, you may recall, resulted in survival past 500 hours, or 20 days, which is long enough for the mice to develop immunities and beat the illness.

The reason that results were different is that the ligand on that optimized injectable version of the drug did not survive in the gut when tested as an oral drug. Fortunately, another ligand was used for the current animal test that easily survives. Moreover, we also know two things that make the 347-hour drug just as effective as the injectable ligand.

First, prior toxicity tests show remarkable tolerance for these nanoviricides, so doses can be upped to increase effectiveness. Second, we know that effectiveness is, in fact, dose dependent. This means that a slightly larger dose of the new ligand would almost certainly take the mice out past the 500-hour mark. Similarly, a human drug could be formulated that would provide a complete influenza cure using the orally deliverable ligand.

I asked Dr. Anil Diwan if that meant that he would take the prior optimized version through the regulatory process for an injectable hospital drug while taking the ligand that survives in the stomach through the process for an oral drug. He responded by saying, that would be logical, wouldn't it, but we're dealing with regulators and we'll just have to see what they want.

It may be that it will be easier to get the stomach-safe ligand approved both for the injectable and oral drugs. We don't know yet. Regulatory approval, of course, is the last hurdle before this world-changing technology comes to market. The company continues to develop its own manufacturing facilities in Connecticut. Even that hurdle could be bypassed by going to a contract manufacturer if the next pandemic hits before the company is ready to manufacture on a mass scale

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