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Posted On: 01/22/2019 10:06:23 AM
Post# of 72446
Meanwhile we are still awaiting news regarding this topic from the 12/17/18 PR.
"Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment. Conducted in accordance with the FDA guidance, the goal of the upcoming studies will be to satisfy requirements for a New Drug Application and, ultimately, obtain marketing approval of Brilacidin for SOM. Management further intends to solicit international regulatory bodies for the purpose of expanded registration globally"
Kelt
"Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment. Conducted in accordance with the FDA guidance, the goal of the upcoming studies will be to satisfy requirements for a New Drug Application and, ultimately, obtain marketing approval of Brilacidin for SOM. Management further intends to solicit international regulatory bodies for the purpose of expanded registration globally"
Kelt
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