Thursday, July 27, 2023 11:26:07 PM
Why would you claim that when the company tweeted an explanation of " it should have read that we requested the pre-sub meeting as per their request."
The entire time it was a submission of genotoxicity protocol to the FDA and part of that submission was a request for the FDA to schedule a pre-sub meeting.
The PITA poster pointed out that the wording was vague and probably meant they weren't meeting rather the meeting was later, and in this case, no matter how unhappy it makes everyone, the PITA poster was right.
The entire time it was a submission of genotoxicity protocol to the FDA and part of that submission was a request for the FDA to schedule a pre-sub meeting.
The PITA poster pointed out that the wording was vague and probably meant they weren't meeting rather the meeting was later, and in this case, no matter how unhappy it makes everyone, the PITA poster was right.
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