Simply put - Brilacidin has been through Clinical Phase 2 trials for use against OM.
So why can IPIX not utilize the FDA Accelerated Approval Route since we cannot currently fund a Phase 3 clinical trial and provide the new optimized oral rinse formulation to patients who need it since it is a debilitating condition which when a patient develops it stops the patient from continuing their cancer treatments until the OM subsides???
The entire FDA Accelerated Approval process was put in place for patients and a company like IPIX who has funded multiple clinical trials and spent tens of millions on product development and still patients are suffering with no clear cut drug for use since a Phase 3 has not been run!