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Re: splintered sunlight post# 163733

Tuesday, 08/08/2023 11:42:38 PM

Tuesday, August 08, 2023 11:42:38 PM

Post# of 176744
Realistic time frame based on most current information:

August: Meeting with FDA to discuss genetox protocol

September-October: CRO runs genetox assays (In vitro AMES and micronucleus assays; maybe in vivo micronucleus assay but I doubt it). RDGL Submits preliminary results to FDA and requests meeting

November: Meeting with FDA + CRO generates report

December: Final IDE is submitted
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