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classics99

09/20/23 2:34 PM

#166195 RE: dekeferrell #166193

The IDE application won’t be submitted until after the next meeting so they can get feedback on their genotoxicity tests. Hopefully, other requirements don’t come to light in that meeting.

SC8

09/20/23 3:22 PM

#166208 RE: dekeferrell #166193

Please, asked and answered. RDGL can't both be in pre-sub program and have already submitted the IDE application which starts a 30 day clock towards approval, conditional approval or rejection. No speculation. All facts.