“there have been no serious sae’s associated with B.”
Actually there have been several SAEs associated with brilacidin. In the opinion of the principal investigator (paid by IPIX) none of these SAEs were caused by brilacidin.
There is a difference between association and causation.
There’s also a reason why many drug safety specialists think that investigators should not pontificate on their view as to whether or not SAEs are treatment related.
When one compares the incidence of SAEs in brilacidin treated subjects versus comparators, it’s difficult for any reasonably dispassionate observer not to be sympathetic to that view.
The sheer number of excess SAEs compared to the comparators constitute a serious signal in themselves.
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