NanoViricides Inc. (NNVC)

[changes_iv]

GUARANTEED SCALABILITY

Attaining unprecedented particle size reduction and a uniform distribution is one thing, but scalability is often another. We guarantee seamless scale-up with unique parallel path micro-channel architecture to achieve consistent process performance and repeatable results; not only from batch to batch, but also from lab environments to pilot and production facilities.

http://www.microfluidicscorp.com/

Microfluidics Corp. has competitors and competitors are to remain competitive as long as they guarantee scalability as well, deliver or, your money back? No one is in business to give money
back!

What company makes the instruments/equipment that made possible scale-up studies? We don't know, or do we? What we do know is that the words "scale-up studies" are no longer being employed in NanoViricides, Inc. PRs.

What we do know from the PRs is:

1- scale-up studies were ongoing throughout 2014

Companies in the field of nanomedicines scale-up, like Microfluidics Corp.,

"...understands that you know your formulation better than anyone. Our engineers in the Microfluidics Technology Center process more than 100 customer applications annually, spanning a uniquely broad range of applications. By supplementing your expertise with this nanotechnology experience, they determine efficient processing conditions to meet your product goals." ~ Microfluidics Corp.

Did you ever read Dr. Seymour expression on one of his emails that the scale-up process was a laborious process?

"...We expect customers to push our equipment to its limits, with consistent and high quality product output. With such high pressures and shear, however, certain parts wear. With Preventive Maintenance, engineers arrive at your facility to identity and resolve potential performance issues before they arise – thus avoiding costly downtime and ensuring the processor operates at peak.

The following services are performed during an annual check-up visit:

-Disassemble the processor down to its “nuts and bolts”
-Evaluate every internal component (seals, gaskets, bearings, etc.)
-Clean and re-lubricate appropriate parts
-Diagnose worn items and replace covered parts as necessary
-Train your staff on diagnosis, maintenance and repair techniques
-Reassemble and test run the processor
-Provide a thorough written report on findings and analysis
-Ascertain customer satisfaction post-service
..." ~ Microfluidics Corp.

2- On January 22, 2015 Nanoviricides, Inc.

...reported a good safety profile of an optimized FluCide® drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.

No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed. There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.

The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.

These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company's positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.

This study was developed in collaboration with BASi and conducted by BASi in a c-GLP-like fashion in order to understand the safety parameters of FluCide intravenous dosing.

The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies.

3- On April 6, 2015 NanoViricides Inc.

..has previously reported that it completed the acquisition of the state-of-the-art nanomedicines manufacturing facility at 1 Controls Drive, Shelton, CT, from Inno-Haven, LLC, by reimbursing Inno-Haven for the costs incurred. This facility will be capable of producing any of the Company's drug candidates in a cGMP-compliant manner in multi-kilogram quantities. This facility will be able to provide the cGMP clinical drug substances for the Company's future human clinical studies. ("c-GMP"= current Good Manufacturing Practices).

The Company has previously reported that the initial safety and toxicology studies of FluCide™ in a rat model were completed at BASi, Inc., subsequent to the reporting period. These studies have continued to demonstrate an excellent safety profile for our injectable FluCide drug candidate, at doses up to 300mg/kg given for 14 days (total 4,200mg/kg).

In addition, the Company is performing process development and scale up studies on its FluCide drug candidate. FluCide is designed as a treatment for influenza in seriously ill hospitalized patients, a potentially fatal disease for which no satisfactory treatment exists. FluCide's excellent safety profile resulted in the need for a very large quantity of the drug for the GLP Safety/Toxicology studies required for an Investigational New Drug ("IND") filing. The multi-kilogram quantities of FluCide needed for these safety and toxicology studies will be produced in the new Shelton facility.

The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of our injectable FluCide™ drug candidate, as well as possibly to advance another drug candidate towards initial human clinical trials. As previously reported, our strong cash position has enabled us to restart our anti-Ebola drug development program in response to the current epidemic. The Company's estimates are based on its current rate of expenditure and also on certain approximate estimates for clinical development of its drug candidate as gleaned from discussions with various contract research organizations.

4- On May 18, 2015 NanoViricides, Inc.

...reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analytics Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility. We implemented a phased program for commissioning the new facility. This has enabled us to continue to progress in all of our existing programs, without interruptions.

The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.

Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. 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. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.

Then on June 1st, 2015 Dr. Seymour states via email that production of FluCide(TM) for Phase III toxicology study, to be shipped to BASi, had started:

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals

MersCide

Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak

EbolaCide

Making more drug for continuation of the testing by USAMRIID.

Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!

Eugene Seymour MD MPH
Chief Executive Officer NanoViricides, Inc [e-mail]
www.nanoviricides.com 310-486-5677
"NNVC" on the New York Stock Exchange

But when exactly did that happen? May 20th, 2015? The commission of the new multi-kilogram Pilot Plant means (3) identical batches of FluCide must be produced, GLP. How long did it take? January to May 2015, (5) months? That is approximately 6 weeks per batch. In other words, (3) months for (2) 1kg batches (2kg). If we assume FluCide production for Phase III toxicology study at BASi began on June 1st, 2015 then, we are getting close to another PR. Successful commissioning of the multi-kilogram Pilot Plant at Shelton, successful 1kg scale-up and shipment to BASi for toxicology study for third and final phase. And of course we know what the result of that final Phase III will be, don't we? A resounding success!

What about the 500g batch to complete the 2.5kg? Why not get it GLP from the old lab? Did we get a new 500g capacity equipment/instruments for the old lab? Was that the first batch made, currently sitting on a shelf, awaiting shipment to BASi?