Ann: IMU Pre-IND FDA Meeting Provides Guidance for KEY-Vaxx, page-7

The meeting would have been requested by IMU, FDA approval is part of the regulatory process for approval of all new human treatments/device usage in the USA. The announcement suggests there is a clear plan for further development of the PD-1 vaccine, with no unforseen regulatory hurdles to be overcome. The time frame from initiation to final approval can take as long as 9-12 months, but is essential for human trials using the PD-1 vaccine. Successful negotiation of this process will remove a major barrier for external party risk in investment in the technology.Its definitely a step in the right direction, it suggests the management of the company have a clear understanding of the process involved, with no unexpected issues identified in the pre submission meeting.