I take it that there will be a placebo arm in the P3 (for the sake of this post assume that there will be) - my question is if a patient taking the placebo starts showing signs of OM, will the trial immediately count that as an OM positive for the placebo and switch the patient to Brilacidin so that the patient doesn't have to go thru the entire OM life cycle? Seems like doing so would also give great data as to how Brilacidin works on just beginning cases of OM - I assume it would do a pretty good job of getting rid of the start up OM resulting from having to have been given the placebo.

I would prefer nobody has to be given a placebo as the medical industry has a lot of data as to what percentage of patients get OM due to head and shoulder chemo/radiation treatment.

Would also think that strong interim data results should give a good chance that Brilacidin could be authorized for treatment early since it has such a good safety history with no systemic buildup.