Is Conditional Approval of DUR-928 Possible?
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Posted On: 05/04/2024 6:00:30 PM
Mortality Benefit: The substantial reduction in mortality observed in the US-specific data aligns with the FDA's mission and strongly supports granting conditional approval.
Positive Safety Profile: DUR-928 was well-tolerated in the trial, further strengthening its case for conditional approval, as safety is a major consideration.
Path to Approval:
US-Focused Strategy: In my opinion DRRX could strategically pursue an initial conditional approval specifically targeting the US market based on the strength of their US data.
Phase 3 Confirmation: A U.S.-focused Phase 3 trial with 90-day mortality as the primary endpoint could further solidify the findings and pave the way for full approval in the US market.
Positive Safety Profile: DUR-928 was well-tolerated in the trial, further strengthening its case for conditional approval, as safety is a major consideration.
Path to Approval:
US-Focused Strategy: In my opinion DRRX could strategically pursue an initial conditional approval specifically targeting the US market based on the strength of their US data.
Phase 3 Confirmation: A U.S.-focused Phase 3 trial with 90-day mortality as the primary endpoint could further solidify the findings and pave the way for full approval in the US market.
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