NanoViricides Inc. (NNVC)

[changes_iv]

Competition? What competition?!?

The 2009 H1N1 influenza pandemic left a troubling legacy in Europe: More than 1300 people who received a vaccine to prevent the flu developed narcolepsy, an incurable, debilitating condition that causes overpowering daytime sleepiness, sometimes accompanied by a sudden muscle weakness in response to strong emotions such as laughter or anger. The manufacturer, GlaxoSmithKline (GSK), has acknowledged the link, and some patients and their families have already been awarded compensation. But how the vaccine might have triggered the condition has been unclear.

Read more: http://news.sciencemag.org/health/2015/07/why-pandemic-flu-shot-caused-narcolepsy

[There, have a wet wad of money and feel fortunate you were one of the few to help us find a problem with our vaccine.

Competition? What competition??? Here is a bit of information about the backbone of nanoviricides(R) meds, PEG:]

PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.

Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.

The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.

Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible.

http://dmd.aspetjournals.org/content/35/1/9.full
[Enter Big Government/Big Pharma fiefdom, the FDA, mandating that NanoViricides, Inc. must find the Maximum Feasible Dose (MFD).

Have Flucide Clinical Trials been delayed by a year, from 2015 to 2016?]

There are those who complain that the tox studies are delayed. I don’t believe that it is the case at all. Had our drug system not produced such amazing initial tox results, we would be well into the BASi studies at this time. The FDA mandates that we find the toxic dose. To do that requires an inordinate amount of material. When the amount of material needed is produced, the studies will start. I feel that it will be quite soon but I cannot, in good conscience, give a hard date. ~ Dr. E. Seymour, CEO of NanoViricides, Inc. --- Jul 20, 2014

[The FDA remained quiet while our government regime gave a lawless pass to drug lord "El Chapo" Guzman's favorite business/drug, toxic Cannabis. Yes "Chapo", you can go forward to market with a simple democrat petition/vote? Sweet, is it? The reality is that most of medical Cannabis would not pass FDA review.]

The authors, from the Yale University School of Medicine, lamented the fact that state approval of medical marijuana had been based on “low-quality scientific evidence, anecdotal reports, individual testimonials, legislative initiatives, and public opinion."

“Imagine if other drugs were approved through a similar approach,” they wrote.

To win FDA approval, drug makers typically have to show that a medicine works in not one but two randomized clinical trials. But for most conditions that qualify for medical marijuana treatment, “the evidence fails to meet FDA standards,” according to the editorial.

“If the goal is to make marijuana available for medical purposes, then it is unclear why the approval process should be different from that used for other medications,” the Yale authors wrote.

http://www.latimes.com/science/sciencenow/la-sci-sn-medical-marijuana-review-20150623-story.html

[Overnight, once the petition is voted on and passed, the lawless drug cartels stop being sociopaths/psychopaths to become legitimate businessmen under the laws of our nation!?! All thanks to a new democrat petition/vote or exceptions to current law!

So, how does this work? Toxic Cannabis can do its clinical trials AFTER it goes to market, racking up millions from the impoverished! I think our small nano drug making company could also use a sweet deal like that with the difference we are low toxicity, effective, independent from the host's immune system and we would be saving millions of lives and 47 to 150 billion a year to the economy. That is BILLIONS with a B!

All of this should always take longs back to the time when we discovered that the FDA had imposed the requirement on our small company, a heavy-handed imposition, to find the toxic dose (MFD) for the toxicological study. Again, the MFD requirement is unreasonable considering the low toxicity profile of FluCide(TM). Low toxicity FluCide(TM) has an excellent safety profile and has been successful with 6000 animal subjects, we cannot fail on our own, but the FDA is helping?

Short bets on margin, unless they engage in high-speed trading, need to be concerned with facts that were presented at the 3rd Annual Influenza Research & Development and the fact that NanoViricides, Inc. started making FluCide for toxicology study Phase III (large animals) on or before June 1st, 2015.

Competition? At this stage of the game, what competition?!?]

Mauldin Economics report excerpt on nanoviricides(R)...

There will always be a need and demand for vaccines, but many people won’t use them. We know this from experience. However, the existence of a nanoviricide treatment for a virus-borne illness means that treatment can begin after symptoms for influenza or some other virus-borne disease appear.

Based on animal studies, we believe that virus populations will be so reduced that symptoms would disappear in only a few hours. Immunity, however, would develop in the normal 21-day period so that the patient could not get the same infection again.

Some viruses—notably hepatitis, HIV, and herpes—might not be cleared entirely from the system because they hide inside various tissues. I believe, however, that symptoms will disappear, and the patient would not be contagious. When the virus emerges, however, it will encounter nanoviricides if they are in the patient’s system. Over time, there is a strong possibility that each reemergence will be smaller than the last, until the disease is gone. ~Mauldin Economics - Build Transformational Wealth from Three Tiny Companies

source: http://www.mauldineconomics.com/download/transformational-wealth-from-three-tiny-companies