Projected Timeline for Investigational Product Immune12 Clinical Trial in the United States.
Currently there are no registered clinical trials for the investigational product Immune12 in the United States. However, we are in process with a US FDA Application and preparatory work. Below is our current planned timeline for these activities. Check back, or sign up to receive update notifications from us.
All dates below are dependent on FDA Timelines
2027
Request FDA Pre-IND meeting
Submission of the formal PMB request to the FDA for a Pre-IND Meeting on Immune12.
FDA Formal Meetings
PMB expecting to attend a FDA Pre-IND Meeting.
Submission of Application
Completion of PMB responses to the FDA request for additional information.
FDA Decision
Anticipated FDA decision on approval of Immune12 proceeding to human trials