The 10Q filed shortly thereafter confirmed it. "We have received back from FDA comments and considerations for incorporation into our study design. An additional round of review and/or a formal meeting is anticipated, both of which can extend the review period and be beneficial in reaching agreement with the FDA on design elements. Based on the FDA's feedback, we may reach final agreement with FDA or may decide to incorporate the advice into the design of the Phase 3 clinical study without undergoing additional rounds of review. FDA's assessment of the SPA request, and all related feedback, will be very valuable in our planned Phase 3 clinical study for the development of Brilacidin for ABSSSI."
You wrote: "FDA worked with the company to develop a protocol for the FDA PH3. As I said." There is no such thing as an "FDA PH3". And the Company's final trial design has to conform to the FDA's requirements, which they either couldn't or chose not to do, rendering the SPA useless. The most recent 10Q provides an update of sorts: "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 the FDA due to the low price per share of our common stock and the many multiple million dollar costs associated with a Phase 3 program. 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."
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