Brilacidin. ABSSSI - In February 2016, Cellceutix 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.
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So I think they gave up the SPA talk for a bit. But I do think that the company may take a full buyout. Just a whisper. They may be aligning all of these PoC and mid phase 2 trials to show BP exactly what htey want with a guaranteed phase 3 new antibiotic sitting there and if K proves out better than expected with a good update on oral ------ we may see a huge buyout. Upwards of 17 billion outright. JMO
Long until Leo sells - CTIX