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splintered sunlight

07/27/23 5:53 PM

#163406 RE: wrinklesobw #163402

Where are you getting that information from?

Thanks
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SC8

07/27/23 6:40 PM

#163408 RE: wrinklesobw #163402

Nope, can't request a meeting with FDA to review a submission until the submission is made so FDA has time to review before meeting. And who on this forum said, in face of much ridicule to the contrary, that the July 6 update didn't at all say there was meeting the following week, only a statement declaring an anticipated submission to be done the following week with further anticipation of reviewing the submission at a meeting, date unspecified?

And what's this revised wording to "week of July 14" mean? July 14 was a Friday. Per original July 6 update, they anticipated submission week of July 10. So guess it wasn't submitted until week of July 17?

Don't feel bad. I'm a technical reader/writer and easily pick up on those details. Most people are casual readers and there's nothing wrong with that. Even RDGL's Twitter flunky misread his boss' July 6 update.
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kayak_wench

07/27/23 11:26 PM

#163416 RE: wrinklesobw #163402

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.