Previously treated patients may be confounding. The strongest possible trial design would NOT have patients previously treated because then it may be argued that the effect of B-OM is actually a result of Previous TXs plus B-OM.
Hope I am answering the correct question here. They will indeed be receiving treatment for their cancer at the same time as receiving Brilacidin to prevent the ulcers which sometimes accompany the mucositis caused by the treatment. If they weren't receiving a cancer drug they would have no OM to treat. They just don't want the results complicated by Pts who may have experienced OM in a previous treatment.
Good morning LR. Didn't make much sense to me either until I realized prophylactic pretreatment with B-OM is designed into the trial protocol.
"This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer." https://www.clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2
They are looking to administer B-OM upon initial treatment for cancer.
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