Replies to post #45820 on NanoViricides Inc. (NNVC)

[BonelessCat]

Phase 1 trials can be conducted from research facilities that establish the equivalence of cGMP. INDs can be tested through the entire process up to and including limited human trials, Phase 1. After Pase 1 is completed, a cGMP pilot facility must be in place. So, scale-up for human testing can be performed out of current NNVC lab space.

Please see Section IV.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf