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If drunk, don't drive. That is good advice.
Did you tout FluDase as Flucide(TM) competition?
NexBio...
-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-government begins to grease skids for the small-biotech, Aug 8, 2005?
-a 50m contract with the NIH, fast-tracked
Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?
It is a fact that our small company, NanoViriricdes, Inc. is advancing towards the completion of Safety/Toxicology Studies/GLP.
The production of FluCide(TM) material, for the third and final phase of tox studies, continues...
What everyone should know about your touted NNVC competition...
-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-small-biotech skids begin to get greased by a U.S. Federal agency, Aug 8, 2005
-a 50m contract with the NIH, fast-tracked
Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?
Another unsupported and biased opinion from an anonymous poster!
Dr. Eugene Seymour's letter March 11, 2014:
Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug, combination and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, quality management, pharmacology/toxicology, quality assurance, GLP, GMP, GCP compliance, program management, medical device biocompatibility, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry.
Our understanding of the FDA enables us to clarify the tough decisions and bring the right balance of business, scientific, and regulatory to product development.
http://www.biologicsconsulting.com/staff-search/?DepartmentId=undefined&Keyword=nanotherapeutics
Anyone that navigates to the Biologics Consulting Group, Inc. website and does a <Search for a consultant by the keyword> "nanotherapeutics", the search will Dr. Nanda K. Subbarao, Ph.D., Senior Consultant.
Nanda has co-authored numerous scientific publications and frequently an invited speaker at Industry Meetings. As a Senior Consultant with Biologics Consulting Group, Nanda utilizes her strong technical skills and expertise in Analytical cGMP systems for both biologics and conventional drugs to assist clients in the following aspects of drug development:
-Set up of cGMP laboratory systems
-Implementation and management of stability programs
-Technical and GMP evaluation of a wide variety of analytical methods at all stages of product life cycle
-Provide technical guidance on method validation for a wide variety of products such as characterized proteins including biosimilars, vaccines, gene therapy products, stem cell products
-Writing and evaluation of method validation protocols and reports
-Specification setting
-CMC analytical sections preparation and review against current regulatory expectations
http://www.biologicsconsulting.com/staff-detail/nanda-subbarao/
It is very likely anything Dr. Eugene Seymour says are highlights within the Biologics Consulting Group, Inc. designed clinical trials, a design within FDA requirements.
Now, whatever anonymous poster JG36 says has as much credibility as anonymous poster JG36PHD. JG36 is an anonymous poster with biased opinions against NanoViricides, Inc.! Me?!? I am an anonymous poster but I quote/reference my sources in most of my post and provide a link. If you want to add credibility to any counterpoint, drop the attitude and start quoting/referencing your sources.
If Dr. Eugene Seymour, CEO of NanoViricides Inc. says Phase 1 of Clinical Trials in one week, one week it is.
The backbone of all nanoviricides(R) drugs is PEG and PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration.. http://dmd.aspetjournals.org/content/35/1/9.full
On August 10, 2015 PRd their most advanced topical Herpes drug candidate --- NanoViricides Reports that the Dramatic Effects of Its Topical Anti-Herpes Treatment were Reproduced Once Again in an Animal Model in a Different Laboratory
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Reports%20that%20the%20Dramatic%20Effects%20of%20Its%20Topical%20Anti-Herpes%20Treatment%20were%20Reproduced%20Once%20Again%20in%20an%20Animal%20Model%20in%20a%20Different%20Laboratory.html
It seems you've capitulated on the completion of toxicology studies - final Phase 3 (2015) and you are already in Phase 1 of the Clinical Trials (2016).
Phase 1 - Will likely involve a small number of participants where a range of dosage levels are tested and any side effects analysed. Dosing will likely take a week.
I'd say (4) weeks...
The usual review cycle takes only 4 to 8 weeks and is based on the submission of a protocol, investigator brochure and if required, an independent toxicology report.
https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-australia#F
News are coming that will reverse the downward trend, that is why you are arguing Phase 1 Clinical Trials.
You should already know that Phase 1 and Phase 2 GLP tox studies have demonstrated low toxicity. Phase 3 won't be any different. "PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration." http://dmd.aspetjournals.org/content/35/1/9.full
We should only be happy that FluCide(TM) is highly effective to make short trials possible.
If you find them funny, perhaps you should make the quotes your signature so that you can laugh every morning, if only for a while.
Here is what Dr. Eugene Seymour, CEO of NanoViricides Inc., said:
Dr. Eugene Seymour, CEO of NanoViricides, Inc., never said Phase 1 in one week or two weeks. Here is what Dr. Eugene Seymour, CEO of NanoViricides Inc., said:
NewMoney, read the freaking financial news!
NanoViricides Short Interest Down 0.9% in July (NNVC)
August 12th, 2015
http://www.dakotafinancialnews.com/nanoviricides-short-interest-down-0-9-in-july-nnvc/346223/
Would you consider "short interest" smart money?
Irrelevant?!? Are you in charge of information censorship for the NNVC board?
Since when are CMC aspects of drug development irrelevant? or is any information about NNVC FluCide(TM) advancement through the regulatory maze irrelevant?
Are you accusing leifsmith with the intent to mislead NNVC board readers?!? Are you omniscient?
What were you trying to do when you claimed the following:
No effort whatsoever to quote/reference sources. Just use copy/paste.
What is a shame is an anonymous poster, full of opinions and he/she/they do not quote/reference their sources in the vast majority of their posts.
Phase I in a week?,...two weeks!!!
Here is how:
Ahem! Allow me get you started on that trip! Here is a link to the "List of largest pharmaceutical settlements" https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
Can you fetch a few more of those criminals? Rawnoc's company/drug from San Diego, California qualifies.
Now, don't go --- Minority Report - Pre Crime Unit --- on us! That is fiction. Post ONLY companies ON RECORD defrauding the United States of America taxpayer.
You recently stated, "I'm not well versed on the science...".
On Wednesday, 12/10/14 you said,
What about the competition to NanoVirircides, Inc. amazing technolgy? I know that not everyone can find that competition but certainly an experienced and knowledgeable anonymous poster like yourself, can! Yes, we can!...Yes, we can!...Yes, we can!...
A knowledgeable and experienced anonymous poster like yourself should be able to provide a source to your claim of a fact. Where is the source to your claim? Otherwise, it is speculation on your part.
=============================================
Is this an example of a fact?
Miller and colleagues are hopeful that a universal flu vaccine will be a reality within the next 5-7 years.
Recently, MNT reported on a study from Columbia University's Medical Center and Mailman School of Public Health in New York, NY, that found text message reminders improved both first- and second-dose vaccination rates among young children.
Flu vaccine coverage remains low among young children overall. However, children who require two doses of vaccine in one season are at particular risk, the authors of that study observed, as less than half of these children return to receive a second dose after receiving their first.
http://www.medicalnewstoday.com/articles/288082.php
Is that with "greased skids" and all?...and the promise of no contraindications, right?
Scientists find new evidence on GSK vaccine link to narcolepsy http://www.reuters.com/article/2015/07/01/us-health-narcolepsy-vaccine-idUSKCN0PB5PN20150701
Simple math? Ever heard of the expression "show your work"? How about showing your work on this "simple math" of yours. We don't want you to trip over "simple math". And while your at it, give us another example (not a bar graph) of the competition out there, of another company that has NOT defrauded the United States of America taxpayer.
As you point out, several things have happened this year, 2015...
1) NanoViricides, Inc. commissioned the new state-of-the-art, multi-kilogram, Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in early Jan 2015
2) On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch.
-We are now making the FluCide(TM) material for Phase III in large animals!
January 7, 2015 PR...
...better said, ingrained in everyone's mind:
Since you, an anonymous poster, have the knowledge and experience, you may want to get ready to request the FluCide(TM) raw data from NanoViricides, Inc. to produce your own Peer-review article. It won't be long before we find out that FluCide(TM)/GLP drug has shipped to BASi for final/Phase III of toxicology studies.
Phase I and Phase II of GLP toxicology studies conducted by BASi do not contradict KARD Scientific, Inc. non-GLP findings.
The non-GLP study conducted by KARD Scientific, Inc. Dr. Krishna Menon, President of KARD and consulting Regulatory Officer for NanoViricides, Inc., advised NanoViricides, Inc. that some of the orally administered drug candidates provided by NanoViricides showed efficacy in combatting highly lethal influenza H1N1 infection in mice. Are you aware of any GLP toxicology studies that contradict KARD Scientific, Inc. non-GLP findings?
NanoViricides Reports That Oral Administration of FluCide®, its Anti-Influenza Drug Candidate Was Effective In Animal Model
WEST HAVEN, CONNECTICUT -- August 13, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that an anti-influenza drug candidate under its FluCide™ program is effective when given orally. The Company has received information that a FluCide drug candidate designed for oral administration has shown very strong efficacy in corresponding animal studies. This information was received from the contract laboratory that performed the studies, namely, KARD Scientific, Inc. The studies involved the same highly lethal animal model the Company has continued to use for its influenza drug development program. The Company is awaiting data from the studies and intends to release additional information as the data are analyzed and studied.
“We are pleasantly surprised that the modifications that we have been studying for the development of a nanoviricide® that can be orally effective have indeed succeeded,” said Anil R. Diwan, PhD, President of the Company. “Molecules that nanomedicines are comprised of are notoriously difficult to develop into orally available drugs. This is indeed a coup for our nanomedicine technologies,” he further explained.
...
Nanoviricides, Inc. has been working on the development of an orally available nanoviricide for several years now. The essential chemistries were finally worked out during the CMC (Chemistry, Manufacturing, and Controls) studies for our current FluCide™ drug candidate. An initial feasibility study to determine whether a nanoviricide anti-influenza drug candidate would work when administered orally was undertaken perviously and had shown positive indications. The Company continued further development and has now completed a definitive animal model study to determine whether one of the FluCide anti-influenza drug candidates was effective when administered orally. The study was conducted by KARD Scientific, Inc. Dr. Krishna Menon, President of KARD and consulting Regulatory Officer for NanoViricides, Inc., has advised the Company that some of the orally administered drug candidates provided by NanoViricides showed efficacy in combatting highly lethal influenza H1N1 infection in mice.
http://www.nanoviricides.com/press%20releases/2012/NanoViricides%20Reports%20That%20Oral%20Administration%20of%20FluCide%C2%AE,%20its%20Anti-Influenza%20Drug%20Candidate%20Was%20Effective%20In%20Animal%20Model.html
[Going back in time to August 13, 2012, NanoViricides, Inc. was working with elements of Chemistry, Manufacture and Controls (CMC) for FluCide(TM), with the specialized equipment/instruments they had at the time. At that time, they may have been able to produce 100g, at most. Today, they have scaled up production at the West Haven lab to 200g. Is there any possibility that they are able to produce 200g batches, CMC (CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch) at the West Haven lab? Is the West Haven lab also a training center for new hires? ]
A sign of a (stock)tsunami is that the water(stock nav) rushes away from the shore, then comes back to higher levels...That is the first indication and then, the water begins rising fast taking out everything in its path. Stay short and ignore the signs of the coming tsunami, at to your own peril.
Your fact is only half of a fact! I have owned-up to the following:
First, you must own-up to the fact that the new state-of-the-art multi-kilogram Pilot Plant is key to the success/commercialization of NanoViricides, Inc. therapeutic drugs.
What you should know about our "juiced-up" competition...
In defrauding a United States of America, the National Institute of Health (NIH - Federal Agency), the executives of the small biotech NexBio doctored timesheets.
How were the timesheets presented to the "Federal Agency", the NIH? Anyone?
Reiterating, what everyone should know about the competition...
-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-skids begin to get greased, for the small-biotech, Aug 8, 2005
-a 50m contract with the NIH, fast-tracked
-Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?
A small-biotech that is privately-held, with Fludase a first-in-class Influenza drug, a 50m contract with the NIH, fast-tracked, phase 2???...how much longer in years before they reach market? Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America taxpayer funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be? Do you see this as normal and understandable? I believe Billy "the kid" and/or John Dillinger would find this normal but, would you? If cash-flow is an issue, maybe they should get a few investors or go public? Any word on that? Care to compare NanoViricides, Inc. Flucide Influenza targets with those of Fludase? HINT: Use Fludase data and Flucide data.
Competition? What competition?!?
GUARANTEED SCALABILITY
Embedded in the April 27, 2015 PR/discussion of the dramatic effectiveness of the Anti-Herpes treatment, you were able to read other news:
GUARANTEED SCALABILITY