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Monday, January 04, 2021 8:21:33 AM
FYI, from the 2017 10-K:
"In February 2016, the Company submitted a Special Protocol Assessment (SPA) request, along with a final protocol, to the FDA, for a Phase 3 clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). We received from the FDA comments and considerations for incorporation into our study design. Management has decided to delay its response to FDA due to the low price per share of our common stock and the approximately $30 million costs required for this study which would result in significant dilution to our shareholders. Our strategy for now is to achieve success with other trials and attract partnering opportunities with significant down-payments and milestone payments which can fund these trials."
(The same paragraph appears in the 2020 10-K with the only notable change being from "the approximately $30 million costs required for this study" to "the many multiple million dollar costs associated with a Phase 3 program".
In the filings that I looked at I didn't see any indication of the dosages proposed by the Company in the SPA request for the Phase 3 and the FDA comments were not published, so I don't think it's correct to say "The FDA didn't see any issues with this P2 trial" regarding dosages (or anything else). I don't think we know.
Did I miss it? Anybody?
“I have had a wonderful time but this wasn't it.”
..........Groucho
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