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Posted On: 02/26/2021 5:24:04 PM
Post# of 72440
Innovation Pharmaceuticals playing multi-dimensional chess. (Give some credit to FDA pre-IND guidance as well.)
It would be unethical and, likely, rejected by the FDA to structure a protocol that pits Brilacidin against SOC. Given the virulence of COVID-19 and the rapid progression toward death, 3 days, potentially, lost to an untried drug would be unacceptable. Anticipating the dilemma Innovation Pharmaceuticals had Brilacidin tested in the RBL’s against both US and EU SOC. The current protocol severely reduces risk for trial participants.
Today’s IPIX PR very clearly stated:
• Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for
3 days
• Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3
days
It would be unethical and, likely, rejected by the FDA to structure a protocol that pits Brilacidin against SOC. Given the virulence of COVID-19 and the rapid progression toward death, 3 days, potentially, lost to an untried drug would be unacceptable. Anticipating the dilemma Innovation Pharmaceuticals had Brilacidin tested in the RBL’s against both US and EU SOC. The current protocol severely reduces risk for trial participants.
Today’s IPIX PR very clearly stated:
• Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for
3 days
• Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3
days
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