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Posted On: 03/30/2019 9:49:49 PM
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PRESS RELEASE
10-Q: INNOVATION PHARMACEUTICALS INC.
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Published: Nov 8, 2018 5:12 p.m. ET
ABSSSI
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 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, the financing of which would likely result in significant dilution to our shareholders. Our strategy, for now, is to achieve success with other trials and attract partnering opportunities that may provide significant upfront payments and milestone payments, which can then be used to fund the ABSSSI program. Although we recognize significant generic competition for treating ABSSSI, we see ABSSSI as the appropriate gateway indication in infectious diseases, enabling potential further studies of Brilacidin's use for implant coating and biofilm infections.
PRESS RELEASE
10-Q: INNOVATION PHARMACEUTICALS INC.
By
Published: Nov 8, 2018 5:12 p.m. ET
ABSSSI
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 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, the financing of which would likely result in significant dilution to our shareholders. Our strategy, for now, is to achieve success with other trials and attract partnering opportunities that may provide significant upfront payments and milestone payments, which can then be used to fund the ABSSSI program. Although we recognize significant generic competition for treating ABSSSI, we see ABSSSI as the appropriate gateway indication in infectious diseases, enabling potential further studies of Brilacidin's use for implant coating and biofilm infections.
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