Replies to post #45916 on NanoViricides Inc. (NNVC)

[BonelessCat]

Not arguing with that. Yes two species. Says so right in those links I provided. Yes sir. You sure are right about that.

But, which species? What if the FDA wants primates? Which primate? How many studies? Which studies must be duplicated? Which studies require more than duplication?

Your so simple a cave man can do it explanation isn't backed up by either the regulations and even less so in the FDA interpreting those regulations for each drug and each disease.

Again, I will repeat, two species is the base. The FDA can ask for a third species after the INDA is filed and reviewed. That's one of those questions that the FDA can address within 30 days of filing. Says so right in those links I provided.