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Re: Rtime post# 98512

Sunday, 07/26/2020 7:51:34 PM

Sunday, July 26, 2020 7:51:34 PM

Post# of 233631
Specific to your response to Item 3.

https://www.fda.gov/media/109758/download

Within 30 days of the date of the review division’s RTF notification, the applicant may request in writing an informal conference with the FDA to discuss whether the FDA should file the application.



I'm going to assume that CytoDyn received the RTF notification on 10Jul20 to assume worst case for the timeline. That means there are 11 business days remaining to respond to the RTF in writing.

That's not to say that this is already been done or is very close to being done. Here on the "outside" - we just don't know.

And judging by prior announcements and subsequent criticism as to timing/content of the announcements....if I were to whisper in NP's ear, I would just wait to announce when it is complete and a response is received.

Maybe we need to change the adage...

"You can make some of the people happy all of the time, you can make the people happy some of the time, but you can’t make all the people happy all of the time".

...should be changed to:

"No one will be happy any of the time - the data will get released some time."
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