NanoViricides Inc. (NNVC)

[bloomvest]

Even with all the material in the world, the FDA is requiring tests that BASi has never done and is not prepared to do, and has no idea how to do them because the tests have not been created or developed. No tox studies and certainly no clinical trials are realistically being planned.


From the 10Q
"Our studies also involve the development of methods of chemical and physical characterization of the materials at various stages in the entire production process. These studies also include performing the syntheses at different scales, and at least sufficiently characterizing the products at different stages to enable decision-making regarding different possible process variations. We are also continuing to develop additional tests that are needed for analyses of samples from animals that will be generated during the safety/toxicology studies, and later in the human clinical trials. Such tests are needed for estimating a drug’s distribution pattern in the body as well as the time profile of the distribution. Such tests are also needed to decipher the metabolic fate of the drug. Since a nanoviricide drug is not a simple small chemical or an antibody, development of these tests is relatively complex, and is taking a significant amount of time."