By focusing specifically on the significantly improved survival outcomes observed within the U.S. patient group in the 2b Trial should substantially strengthen DUR-928's potential for FDA approval for the following reasons.
Enhanced Statistical Significance:
I believe the 57% and 58% reductions in 90-day mortality observed in U.S. patients for the 30mg and 90mg doses respectively, are both clinically significant and statistically compelling (p-values of 0.014 and 0.008). This data solidifies the initial signal seen in the overall trial, surpassing the conventional p-value threshold indicating a strong treatment benefit.
Implications for FDA Approval:
Clear Benefit: The U.S. specific results demonstrate a compelling survival benefit for American patients with severe AH.
Supports Further Trials: I believe the positive U.S. findings strongly justify a U.S. focused Phase 3 trial with 90-day mortality as the primary endpoint.
Overall Impact:
In my opinion focusing on the U.S. patient data dramatically transforms the 2b Trial results. It moves DUR-928 from the realm of a promising potential therapy to a drug with demonstrable, statistically significant survival benefit. This finding leads me to be highly bullish about the prospects of FDA approval and the potential for DUR-928.
Expected Impact of Mortality on P-Value:
I believe factoring in transplants as live patients would likely lower the overall mortality rate within the U.S. larsucosterol groups even further.
Stronger Significance: In my opinion this decrease in mortality for this group would likely push the p-value to a highly statistically significant level (potentially well below 0.001).
Enhanced Statistical Significance:
I believe the 57% and 58% reductions in 90-day mortality observed in U.S. patients for the 30mg and 90mg doses respectively, are both clinically significant and statistically compelling (p-values of 0.014 and 0.008). This data solidifies the initial signal seen in the overall trial, surpassing the conventional p-value threshold indicating a strong treatment benefit.
Implications for FDA Approval:
Clear Benefit: The U.S. specific results demonstrate a compelling survival benefit for American patients with severe AH.
Supports Further Trials: I believe the positive U.S. findings strongly justify a U.S. focused Phase 3 trial with 90-day mortality as the primary endpoint.
Overall Impact:
In my opinion focusing on the U.S. patient data dramatically transforms the 2b Trial results. It moves DUR-928 from the realm of a promising potential therapy to a drug with demonstrable, statistically significant survival benefit. This finding leads me to be highly bullish about the prospects of FDA approval and the potential for DUR-928.
Expected Impact of Mortality on P-Value:
I believe factoring in transplants as live patients would likely lower the overall mortality rate within the U.S. larsucosterol groups even further.
Stronger Significance: In my opinion this decrease in mortality for this group would likely push the p-value to a highly statistically significant level (potentially well below 0.001).
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