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Re: changes_iv post# 97905

Monday, 09/01/2014 8:29:10 PM

Monday, September 01, 2014 8:29:10 PM

Post# of 146208
Because time waits for no one, it is paramount we get to the Clinical Trials in Australia (2015).

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 longest study in the nonclinical safety assessment is that for genotoxicity, the duration ranging from 13 to 26 weeks. Most studies take 13 weeks or less, including dose ranging studies. One year to complete tox studies for a drug that has shown no toxicity in the histology of 6,000 animals is an absurd claim. Even highly toxic oncological drugs take 9 months on average.

Source:
Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations.
edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown


If we get EbolaCide efficacy in-vivo tests completed successfully I expect NanoViricides, Inc. to join Glaxo Smith Kline and Tekmira in a race, through clinical trials, and to produce Ebola antiviral drugs.

About vaccines...

The number of targets is only limited by availability of resources. There are a large number of viral diseases that do not have good medicines or vaccines available against them. And Nature keeps throwing new challenges at us constantly. Like the SARS outbreak, and the recent H1N1/2009 "swine flu" pandemic.
...
Vaccines have been developed but did not show promising results in their earlier incarnations. This may be because of the ADE effect. Currently a tetravalent vaccine is in clinical trials and appears to show protection. Nevertheless such vaccines are not expected to protect 100% of the people that take them, but possibly only about 30-50%. Besides, vaccines usually fail with the emergence of mutated viruses. And when a person develops a disease, we still need to have a treatment.


http://www.internano.org/content/view/541/292/

Glaxo Smith Kline and Tekmira are going to enter their respective Ebola vaccine Clinical Trials for safety however, if vaccines "usually fail with the emergence of mutated viruses" then what??? Who is going to keep tabs on efficacy for these two vaccine makers or us, if we join in the race? Hopefully they have a plan because you just don't want to throw more money at a deadly problem as Ebola.

Related:

As Ebola Outbreak Expands, These Experimental Drugs Could See Action
http://www.forbes.com/sites/scottgottlieb/2014/08/18/as-the-ebola-outbreak-expands-these-experimental-drugs-could-see-action/

Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments
http://www.raps.org/Regulatory-Focus/News/2014/08/07/19977/Regulatory-Explainer-What-You-Need-to-Know-About-the-Regulation-of-Ebola-Treatments/

In the presence of a suspect case of Ebola, the official CDC website details 'Specific Laws and Regulations Governing the Control of Communicable Diseases', under which even healthy citizens who show no symptoms of the virus could be forcibly quarantined at the behest of medical authorities. The existing regulations stipulate, "Quarantine is used to separate and restrict the movement of well persons who may have been exposed to a communicable disease to see if they become ill."

In other words, you don't have to be sick to be detained. Just suspected by health officials of having been in contact with someone who might have had the disease.

The regulations say a person "may be detained for such time and in such manner as may be reasonably necessary." Is that three days or thirty? There are no rules.


How the health system would respond if Ebola spread on U.S. soil
http://www.advisory.com/daily-briefing/2014/08/14/how-the-health-system-would-respond-if-ebola-spread-on-us-soil

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