"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].
1) NanoViricides, Inc. commissioned the new state-of-the-art multi-kilogram Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in Jan 2015 2) On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide(TM), 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 third and final/Phase III of Safety/Toxicology Studies 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
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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
Dr. Milton Boniuk, an independent director/insider, an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator, 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. . . .
About Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study.
Abstract
Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.
FROM THE CLINICAL EDITOR:
Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness. http://www.ncbi.nlm.nih.gov/pubmed/23969105
