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. The Company has previously reported that its FluCide candidate was highly effective in animal models of different influenza A virus strains. In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress.
What some people are trying to distract others from is this particular paragraph and what it actually says. It says that the company acknowledges that "large" quantities are required from a GLP facility. It also says that the company has undertaken the 'process development' to 'enable' scale up in the old non GLP facility.
Excert... As previously reported, the results of this study will provide both the basis and focus for the GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These GLP studies will be performed on both large and small animals at the BASi facility in Indiana.
A critical step in FluCide drug development is the ability to produce clinical scale drug product. The Company has previously reported that the renovation of its facility in Shelton, CT, for its new clinical scale production plant is in the construction phase with projected completion during Q1 2014. The Company is performing certain scale up studies for manufacturing FluCide at its current facility.
The company says that the construction phase of the new facility is being completed. It goes on to say that the 'studies' for scale up are ongoing at the old facility.
Upon sending the initial non GMP material 200g from the old facility the company sent this PR dated Oct 1, 2014... http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20FluCide%20Samples%20Were%20Shipped%20To%20BASi%20For%20Start%20of%20Safety%20Toxicology%20Studies%20Also%20Reports%20That%20Ebola%20Drug%20Candidates%20are%20Being%20Synthesized.html An important excerpt from this PR, With this information, and in consultation with BASi, we designed the safety/toxicology protocols for certain starting studies. We estimated that the total "Tox Package" studies would need as much as 2.5kg of the drug substance. Recently we broke up the study into parts and developed a starting study protocol that would require a 200g batch. Simultaneously, we have successfully scaled up our synthesis processes in the current Wood Street facilities, to be able to produce a 200g batch. The material we produced has gone through certain tests for its quality. We then prepared the samples as per the protocol design, and we have shipped them to BASi yesterday.
It is very clear when reading the PR's in chronological order that the company publicly stated that it required large quantities of GLP manufactured material for Flucide Tox studies in 2013. It also acknowledged it required the material from the new facility (which was under construction) to complete the Tox studies. All that is required is to read the PR's in order and anyone with a decent level of reading comprehension can see that everything the company said makes perfect sense and their were no lies.
A. The company acknowledged requiring large Quantities of Flucide in 2013 B. They acknowledged that to complete the studies the material would be required from the new facility (GMP facility) C. Scale up 'process' was being worked on in the old facility D. The new facility was in still in construction phase in 2013 (not installing and validating equipment phase) E. They broke the study up into non GLP and GLP to make use of the 200g scale up at the old facility.
Any other take on this matter is purely fictitious!
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