"The FDA does not grant compassionate use for drugs at the end of a Phase 2 trial without some indication of efficacy from the still blinded or unblinded data."
That's bullshit.
And the bolded bit particularly is even more wrong.
By definition no one knows anything about efficacy when the study is still blinded.
And we know that the study is still blinded because data lock is not expected until mid- or late October.
I would substitute the word "might" be working, for "is" working. Without access to some data from patients who participated in the trial, no way would the FDA grant companionate use IMO.
Another nugget… The company has received… “ Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy.”
Requests and patients, both plural. Leo also mentioned BrilAcidin was shipped to relevant hospitals so more than one location and, possibly, more than one physician. More than one patient and more than one request. My guess is this is related to trial participants.
I'm confused about what kind of signals this would be if the data is still unknown to everyone. Would it be trial participants seeing clear evidence of something going on?
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