"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
About commissioning and validation of the new, state of the art, Pilot Plant in Shelton, CT:
Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus [3].
We are currently making the FluCide(TM) material for final/Phase III in large animals!
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals . . . Eugene Seymour MD MPH Chief Executive Officer NanoViricides, Inc eugene@nanoviricides.com www.nanoviricides.com 310-486-5677 "NNVC" on the New York Stock Exchange
Now, who do you believe, a "Tokyo Rose"-like anonymous poster with many aliases, posting from somewhere in Washington, D.C., New York City - Wall Street "con" office, California/Big Pharma "cons" office, all trying to scare "longs" out of their wits/NNVC shares by using their financial might to drive the nav of NNVC shares to a new low?...or do you believe Dr. Milton Boniuk, an independent director/insider who is buying with great frequency and confidence?
NanoViricides Appoints Baylor Professor Dr. Milton Boniuk as an Independent Board Member
WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has appointed Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, as an independent member of the Company’s Board of Directors.
Dr. Boniuk is an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator. Currently, he is the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX. He conducts a busy clinical practice in orbital surgery, eyelid reconstruction, ocular oncology and comprehensive ophthalmology. Additionally, he plays a major role in Baylor’s resident and fellow medical doctor education programs.
Dr. Boniuk has been a long term investor and strong supporter of NanoViricides, Inc.
“Milton’s strong business acumen, integrity, and professional expertise will be of great help in strengthening our corporate governance as well as fostering our drug development activities,” said Eugene Seymour, MD, MPH, CEO of the Company.
Dr. Boniuk has made significant contributions in cataract surgery, glaucoma, corneal dystrophies, retinal diseases and surgery. He is a nationally and internationally recognized expert in the pathology and surgical management of orbital and intra-ocular tumors. His description of the ocular pathology of the congenital rubella syndrome in 1967 was a landmark publication. Of note, Dr. Boniuk has made substantial medical contributions in areas that are of great significance to the Company, such as ocular adenoviral infections, that cause epidemic kerato-conjunctivitis (EKC). The Company has developed a drug candidate for EKC infection that was successfully tested in rabbits. These animals serve as a surrogate for the viral disease in human eyes.
“Dr. Boniuk brings a unique set of skills to the Board of NanoViricides, Inc.,” said Anil R. Diwan, PhD, President of the Company, adding, “He shares our enthusiasm for the novel biomimetic nanoviricides® technologies and the resulting anti-viral drugs. In addition to strengthening our corporate governance, he will be of great value in progressing our drug development programs into the clinic.”
Dr. Boniuk is also well known for his philanthropic endeavors. He and his wife Laurie founded the National Society for Parent and Child Development in 1989. In 1994, he established the Lions Eye Bank Foundation’s Milton Boniuk, M.D., Endowment Fund to support resident research in the Ophthalmology Department at Baylor. In 2004, Milton and Laurie Boniuk contributed $5 million to Rice University to establish the Boniuk Center for the Study and Advancement of Religious Tolerance. In 2013, they gave an additional $28.5M to Rice University to upgrade this Center to The Boniuk Institute for the Study and Advancement of Religious Tolerance. The Boniuk Institute will conduct research, public outreach and educational programming. Its mission is to foster multidisciplinary research that leads to innovative ways to understand and achieve religious tolerance.
Dr. Boniuk earned his MD at the Dalhousie University, Halifax, Nova Scotia, Canada, followed by an internship at the Victoria General Hospital, Halifax, Nova Scotia, Canada, and Residency at the Center for Ophthalmology, Jefferson Medical College - Wills Eye Hospital, Philadelphia, PA. In addition, he served a Fellowship in Ophthalmic Pathology at the world-renowned Armed Forces Institute of Pathology, Washington, DC. ...
We are making the FluCide(TM) material for the third and final phase of the Safery/Tox studies. Once we reach the 2~2.5kg needed, it will be shipped to BASi and soon enough Phase III of Safety/Tox studies will begin and complete with the expected excellent results we've observed in the past. This goes to prove, once again, what many in the scientific community already knew...
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.
PEG is the backbone of all nanoviricides(R) drugs and this is very important because...
Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna
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"I suppose" the "con blogger", "Pump Terminator", could soon be coming out of his closet to reiterate everything he has blogged about our small company in the past, plus an update on why he/she/they believe the risk has jumped from 80% to 99%. "I must confess", I feel pretty confident the sociopath/white-collar criminal will not be outdoing himself and instead rely solely on minimum wage cons/alias/anonymous posters.
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
