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Anyone know, has NNVC ever completed a complete set of toxicology studies required for human studies?
"Fooling viruses using their own smarts" Thats on the NNVC home page. They are pretty clever with their bag of fooling tricks!
They don't want it. Because we all know they are sitting on the cure for cancer. How difficult is it to cure viruses?
NNVC is all about smoke and mirrors. It's time for the CT AG to take a look at their lies over the many years that financed the lavish lifestyles of the Diwans.
If anyone can do it it's Diwan. he's so smart. After all he has an amazing track record of developing.......
nothing. I couldnt find a single thing that is credible.
Got it!
They talk about everything except when they will complete the tox study. I believe this is the minimum needed for an IND filing...and that has nothing to do with efficacy. I googled AR Biosystems. So Dr. Krishna Menon - President & CSO - AR Biosystems is now doing the research and validating the science? This is too funny.
If they haven't started their tox study yet they are at least a year away from starting a clinical study. They could have already filed their pre-IND a year ago. Why haven't they?
Wait there is still no toxicology study. "Pharmacology is the scientific discipline that studies the mechanisms by which drugs alter biological systems in an attempt to improve health and alleviate disease, whereas toxicology is the study of mechanisms by which drugs and chemicals in the environment produce unwanted effects."
But...everyday NNVC is selling its cides its making $69,358,488.96. How does that figure in your calculations? Meanwhile every year the company flounders Diwan and Seymour make $15,000,000.
New SEC coming. You hear that Diwan and Seymour!!!
But Seymour said they'll have billion dollar drugs developed in weeks?
AIAIR Award 2017...Anybody know if there is a Scam of the Year Award?
Huge Herpes Outbreak.....
Anybody know if NNVC headquarters was effected?
Diwan and Seymour were large contributors to Hillary. They are frightened now that the new SEC will enforce laws.
I have a bet with Seymour if Herpecide will grow nose hair. A HUGE market if he can then shift to butt hair Results are coming soon.
Relax Magnus, I assure you Diwan and Seymour will write up the press release to report the drug is 550,000 times better than whatever. Regardless NNVC will decline.
So Diwan and Seymour are doing everything second rate and hoping for a miracle? Figure it out. NNVC is a scam.
Show us one single company that used materials manufactured in a non gmp facility, had a glp tox study, and was able to get an IND.
Wrong.
Excellent point. How can you do a tox study acceptable to FDA if the next batch may be different? It's incredible people dont get it that Diwan and Seymour deceived them into believing NNVC had started FDA qualifying tox studies
I agree. Its amazing how people can say a pharmaceutical company would use materials not manufactured in a GMP facility for a tox study. They'll be laughed out by the FDA. Well I guess it fits well within the great scam of Diwan and Seymour.
Sorry Trendliner. But you are incorrect. People often mistake GLP with GMP. See my previous post.
KEY POINTS
The following key points are discussed:
• There is confusion regarding the appropriate applications of good laboratory
practice (GLP) regulations and good manufacturing practice (GMP)
regulations, especially with regard to when they should be applied
• There may be a preference for working under GLP based on the belief that
GLP regulations are less onerous and less costly than GMP
• The GMP definition of “manufacturing” includes testing and quality control
of drug products
• GLPs are intended for non-clinical laboratory studies
• GMPs apply to products manufactured for administration to humans
• FDA has recently issued CGMP for Phase 1 Investigational Drugs that removes
rules not appropriate for early stage development
• Current good manufacturing practice regulations clearly apply to phase 2
and phase 3 clinical materials
• GLP has specific requirements not common to GMP laboratories that
potentially add cost and time to project completion
• All things considered, there is nothing onerous or particularly difficult
about the GMPs.
http://www.ivtnetwork.com/sites/default/files/GLP-and-GMP-in-Contract-Testing-of-Drugs-and-Biologics.pdf
KMBJN. You really are still confused. Here it is Simply stated :
People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles.
GLP and GMP regulations pertaining to testing serve two different purposes. The GLPs are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to the FDA whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.
In general, "lot release" or "lot conformance" testing of regulated products produced for sale, like finished pharmaceuticals, should be done under GMP. Safety testing and efficacy testing should be done under the GLP testing regulations. It is a matter of debate whether validation studies should be done under GLP or GMP. It may depend on what is being validated; in some cases either GLP or GMP may be appropriate.
http://microchemlab.com/what_is_the_difference_between_GLP_and_GMP_lab_testing_regulations
Is it true Diwans 95 year old aunt on Theracores payroll being reimbursed by NNVC (plus 30%).
I've been so wrong since I first pointed this out when NNVC was over $3. Gee what am I missing?
2.2. Test Article
The material used in the definitive Good Laboratory Practices (GLP) nonclinical studies
does not need to be Good Manufacturing Practices (GMP) grade material, but it does
need to be characterized with a Certificate of Analysis, or equivalent, that contains the
following information: identity, purity/strength, composition, and stability/retest date.
Often the term “GLP material” will be used; however, this is a misnomer since the GLP
regulations do not apply to manufacturing, and so the use of the term “characterized
material” is more accurate when discussing the material to be used in a GLP nonclinical
study. The material to be used in the nonclinical studies should be representative of the
material to be used in the clinical study regarding impurity profile, salt form, strength,
and other factors. Significant differences in the material used for nonclinical studies
compared to that used in clinical studies could require additional bridging studies to
evaluate these differences before initiation of clinical studies.
KMBJN, Are you serious? "Nanoviricides Announces Initiation of Toxicology Study of FluCide®.
WEST HAVEN, CONNECTICUT -- Monday, October 7th, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), reports that it has initiated the initial non-GLP toxicology evaluation of its optimized injectable FluCide® drug candidate. This study is an important step in the drug development pathway for FluCide. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway.
The non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These IND-enabling GLP safety and toxicology studies will be performed by BASi Toxicology Services in West Lafayette, IN.
http://www.nanoviricides.com/press%20releases/2013/Nanoviricides%20Announces%20Initiation%20of%20Toxicology%20Study%20of%20FluCide.html
Are you serious? You said "I also disagree with you about whether or not drug produced under GMP conditions are required for tox." If they are not manufactured under cGMP conditions how do you know what you're testing? Absolutely required for FDA. BIG LIE BY NNVC and Scammin Seymour
But with the patents they will throw in Diwan and Seymour
I stand corrected. NNVC has zero value. Thank you Arvitar for pointing this out.
No tox studies that would be acceptable to the FDA ever started as we learned they never had GMP materials. Their PR was all false. Thats how come it was easy for me to predict years ago that tox wouldnt be completed for many years. Flu-cide was always hust around the corner. LOL Scammin Seymour and Anil Dunce Diwan
What happened to Flu-cide? Tox studies? Those were also lies
You mean Scammin Seymour is scamming?
Is that the day SEC locks NNVC doors?
The Securities and Exchange Commission claims the makers of a so-called HIV treatment made from goat's blood bilked investors of $20 million while concealing that the Food and Drug Administration had twice put human trials of the drug on hold.
The SEC says Immunosyn Corp. called its drug SF-1019, and claimed it could treat a variety of diseases, including AIDS, chronic inflammatory demyelinating polyneuropathy, diabetic neuropathy and diabetic ulcers.
Immunosyn misinformed investors that its parent company, Argyll Equities, "planned to commence the regulatory approval process for human clinical trials in the U.S.," according to the complaint.
"In fact," the SEC says, "persons affiliated with Argyll had already twice submitted applications to the U.S. Food and Drug Administration for approval of SF-1019, and twice the FDA immediately responded with a full clinical hold on the applications, putting an immediate halt to any possible human clinical trials."
The SEC also sued Immunosyn CEO Stephen Ferrone and CFO Douglas McClain Jr., Argyll CEO James Miceli and Argyll's Chief Science Officer Douglas McClain Sr., who is the father of Immunosyn's CFO.
"These defendants engaged in insider trading by selling Immunosyn shares while in possession of material, nonpublic information that the FDA had issued a full clinical hold on applications for regulatory approval of SF-1019 and while knowing that Immunosyn was making misleading statements about the status of the regulatory process," the SEC says.
McClain Sr. is also accused of misrepresenting the drug's prospects with the FDA on a video on the company's website, and at a presentation at a Texas holistic clinic.
Miceli is accused of ordering the issuance of a false press release that disputed "rumors" that Immunosyn was exploring a change in control.
"In fact, when Immunosyn issued this press release, Miceli [was] actively exploring such a transaction by trying to take the company private," the SEC says.
The SEC seeks disgorgement of ill-gotten gains and fines.
And NNVC's only independent test of a cide was by the US Army and cides failed miserably. The report card had a big red "F".
I confess! I was the big buyer yesterday. I'm planning on holding on to $200 a share.