'Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
https://www.fda.gov/drugs/types-applications/...pplication

Today FDA turned a competitor down as that company was smoke and mirrors.
IPIX is not.

Good luck. Go IPIX