Replies to post #54835 on NanoViricides Inc. (NNVC)

[BonelessCat]

Dr. F: do you know how this kind of relationship works? i.e. between NNVC and BCG?

The relationship is that BCG isn't simply a consultant. They look for information gaps and request data and then re-review. They anticipate questions from the FDA and try to answer those questions, and any questions, the FDA is likely to have. Their duty is to compile the package and review over and over until they feel they have the strongest possible package they would submit to the FDA. This is not just a pre-IND deal. BCG will be involved directly in the process from now until the NDA review at the end of clinical trials.