You still think NNVC is doing this in a vacuum? There are presentation materials from NNVC in the FDA archive. They were reposted recently so should be easy enough to find. The officers have been to two FDA workshops for drug development and approval. The company officers include a professional with 25 years of experience with the FDA. The company s doing exactly what the FDA requires and has outlined they do for preclinical and pre-toxicology characterization or the platform.
Oh, and the pre-IND has to be formally requested and then all materials are submitted. The "phone call" is a conference call that takes about an hour. There is back and forth involved. It's not just call em up as some have suggested.