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Will Rezolute's RZ358 achieve primary endpoint in Phase 3 trial by end of 2024?
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Resolution / Starting Odds
Yes • 50%
No • 50%
Rezolute Inc official press releases or FDA announcements
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FDA Lifts Partial Hold on Rezolute's Phase 3 Treatment for Congenital Hyperinsulinism
Sep 9, 2024, 12:00 PM
Rezolute Inc announced on Monday that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its experimental treatment, RZ358, for congenital hyperinsulinism. This decision allows the inclusion of U.S. participants in the ongoing Phase 3 study. The treatment aims to address low blood sugar levels associated with the condition.
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Yes • 50%
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Meets primary endpoint • 25%
Fails primary endpoint • 25%
Mixed results • 25%
Trial not completed by end of 2025 • 25%
Positive results • 25%
Negative results • 25%
Mixed results • 25%
No results announced • 25%
Positive outcome with significant efficacy • 25%
Mixed outcome with limited efficacy • 25%
Negative outcome with no efficacy • 25%
Trial terminated early due to safety concerns • 25%
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Yes • 50%
No • 50%
Yes • 50%
No • 50%
Significant reduction in reactions • 25%
Moderate reduction in reactions • 25%
No significant change • 25%
Increase in reactions • 25%