(Total Views: 325)
Posted On: 04/25/2019 9:55:45 AM
Post# of 72446
The attempt to conflate utterly different things is very telling.
Breakthrough designation is not an FDA judgment on efficacy of a Phase 2 clinical trial. To claim that "the FDA does not think" that it was efficacious, as two of the multi-identities say, is incorrect. This is not a judgment as to efficacy or of the success of a clinical trial.
Something can be tremendously successful without getting breakthrough designation, which is given under certain conditions that involve subjective judgment by a bureaucrat.
The FACTS are that Brilacidin-OM was stunningly effective for the dose of cisplatin that is usually given. No amount of dodging that alters the FACTS.
Brilacidin-OM was the FIRST treatment to prevent oral mucositis and when it did not prevent it, it reduced the severity and duration.
Look at the links I posted. Those are actual facts, not just calumnies from people with ill intent toward this company.
Breakthrough designation is not an FDA judgment on efficacy of a Phase 2 clinical trial. To claim that "the FDA does not think" that it was efficacious, as two of the multi-identities say, is incorrect. This is not a judgment as to efficacy or of the success of a clinical trial.
Something can be tremendously successful without getting breakthrough designation, which is given under certain conditions that involve subjective judgment by a bureaucrat.
The FACTS are that Brilacidin-OM was stunningly effective for the dose of cisplatin that is usually given. No amount of dodging that alters the FACTS.
Brilacidin-OM was the FIRST treatment to prevent oral mucositis and when it did not prevent it, it reduced the severity and duration.
Look at the links I posted. Those are actual facts, not just calumnies from people with ill intent toward this company.
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