(Total Views: 354)
Posted On: 04/24/2019 11:55:14 AM
Post# of 72448
I believe they would have a placebo as well. Just assuming based on yesterdays PR referencing the study they did.
I also like the idea of switching the patient over to brilacidin if they do get OM while in the placebo. But they should get the planned number of patients in the B arm and not including the patients from the placebo being switched as one of the B arm patients. That should be tracked separately.
Need to see the protocol.
I also like the idea of switching the patient over to brilacidin if they do get OM while in the placebo. But they should get the planned number of patients in the B arm and not including the patients from the placebo being switched as one of the B arm patients. That should be tracked separately.
Need to see the protocol.
Quote:
In reply to
Wednesday, April 24, 2019 11:54:37 AM
Post# of 55456
Posted On: 04/24/2019 10:24:48 AM
Posted By: petemantx
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.
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