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Biotech / Medical : NNVC - NanoViricides, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: HardToFind who wrote (4826)	6/2/2015 7:27:21 PM
From: HardToFind	Respond to of 12871

Nanotoday, With regard to the following paragraph on p. 29 of the latest 10-Q: "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." I thought it was reasonable to question the impact (if any) on the large-animal tox test protocol, so I posed it to Dr. Seymour. He indicated that this does not imply a change to the BASi large-animal test protocol, but this is just additional process and characterization testing as a part of our CMC (Chemistry, Manufacture, and Controls) studies prior to sending the drug candidate to BASi for formal tox testing. So far, the intent appears to be that the large-animal tox test protocol is not changing from the original plan. - HTF