Nonclinical and Clinical US Regulatory Strategies was done by Weinberg.
Service Agreement was signed with Fred Hutch as Contracted Manufacturing Organizaion (CMO).
FDA received our Pre-IND meeting request letter.
U.S. Provisional Application No. 63/092,239 was electronically filed with the U.S. Patent Office.
FDA responded to our pre-IND package by providing its clear and complete guidance, which was sufficient for us to finalize the IND package.