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Saturday, December 09, 2023 4:22:17 AM
What more could the fda pull out of its ass for further testing ? I'm thinking they have run out of runway for more animal tests .If they submit by March we could see approval no later than 30 days from time of submittal . Maybe , we get lucky and they submit earlier.
How long does it take to write a report ?
VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).
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