NanoViricides Inc. (NNVC)

[BonelessCat]

>>why have we not heard of application process in other countries?

Several reasons. First, the path to FDA approval is so rigorous that all other countries have fewer trials and take less time. So, once the pre-IND advisement is complete no matter what will be required for FDA approval, any other country's approval process will be satisfied much sooner. Secondly, it's difficult to discuss other country's application process since each nation is unique. The application process can vary from simply meeting the criteria demanded by the Minister of Health to an established process modeled on that of the FDA (but fewer subjects and Phases). So, once a manufacturing facility is GMP compliant and safety studies are completed, material can be sent to any number of countries for immediate use on human subjects, with the only demand being permission of the Ministry of Health. In some smaller nations, approval can be achieved in about a year.