Replies to post #87735 on NanoViricides Inc. (NNVC)

[MinnieM]

You'll find your answer in this document:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073246.pdf

The company states that none of the treated animals have died from the current doses used. Only non treated animals have died thus far. The FDA likes to see a limiting dose in preclinicals before going on to the clinicals. At least, that is my understanding.







In Reply to 'leifsmith'
What's the FDA reasoning that prevents the amount of a drug required for tox (BASi) to be some reasonable multiple of the expected therapeutic dose, say 10x or 20x? Why require so much of a drug, in our case Flucide, that it is absurdly beyond anything that would ever be used?