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mc73

07/13/23 12:00 PM

#163092 RE: S ceeate #163087

I read it that way as well. They will submit the protocol at the pre-sub meeting. When they get feedback on the protocol isn't mentioned so it could be weeks or months before FDA gives a response on the protocol. They may also turn an response around within a week or 2....we will see
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splintered sunlight

07/13/23 12:10 PM

#163093 RE: S ceeate #163087

Next week we will submit the protocol to the FDA for review at a Pre-Sub meeting