"Again please provide a link showing an efficacy analysis?"
October 2, 2020
Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin for the Treatment of COVID-19
"In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19."
"Target enrollment is 120 patients, with a planned interim analysis."
Why would you think that this CEO meant anything other than an efficacy analysis? Safety is monitored on an ongoing basis.
November 2, 2020
Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
"The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19."
There was no mention of a "planned interim analysis" then or since.
What we learned 3 months later:
February 26, 2021
Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients
"The study protocol provides for 3 days of study drug administration."
"After an interim review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days."
Was the "planned interim analysis" floated in October the "interim review" conducted to assess the advisability of extending the dosing schedule in the trial?
This is exactly why I responded to an earlier question with "I think that the CEO needs to do something about his credibility...and his timetables....and the clarity of his public statements."
I'm tryin ta think but nuttin happens......Curly
