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Thursday, January 14, 2021 7:40:23 PM
I still don't get it.
Fast Track for B-OM was granted 15 months after the Phase 2 was started. Obviously it had to have been applied for long after the P2 started. Were they at risk for protocol modifications and a reapproval "for accelerated chains of assessment"? Did those things happen?
Did you notice this in today's PR?
"To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation)."
So they received Fast Track for B-ABSSSI except they didn't receive Fast Track for B-ABSSSI....they're eligible for it and need to apply, right?
The 10-K supports the fact that FT hasn't been received for B-ABSSSI: "Certain of our product candidates, such as Brilacidin for the indication of Oral Mucositis and Kevetrin for the indication of ovarian cancer, have been awarded Fast Track designation."
Where is B-ABSSSI?
“I have had a wonderful time but this wasn't it.”
..........Groucho
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