(Total Views: 781)
Posted On: 10/10/2020 12:06:28 PM
Post# of 145890
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Here's a question regarding the FDA's current views on improvement of SOC for COVID over last several months and an EUA for LL. Has it occurred to anyone that the FDA might require the CD12 trial to continue to full enrollment even though the interim results are statistically significant at p <.05. Their reasoning being that since the SOC has improved, the additional enrolled patients will better reflect the potential efficacy of LL in future months. I'm aware that others here have noted that the improved SOC shouldn't significantly impact the efficacy calculations but one wonders what the FDA considers in their EUA evaluation.
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