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Posted On: 08/20/2020 10:55:56 PM
Post# of 153802
Re: clambottler #51023
To Avoid Delay, the FDA Recommends CytoDyn Conduct Its Type A Meeting in Writing with FDA Response Goal Date of September 4
I don't see how Bruce's presence factored into the FDAs recommendation for a WRO (Written Response Only) Type A meeting.
https://www.fda.gov/media/109951/download
IV. MEETING FORMATS
There are three meeting formats: face to face, teleconference/videoconference, and WRO as follows:
(1)Face to face — Traditional face-to-face meetings are those in which the majority of attendees participate in person at the FDA
(2)Teleconference/Videoconference — Teleconferences/videoconferences are meetings in which the attendees participate from various remote locations via an audio (e.g., telephone) and/or video connection
(3)Written response only — WRO responses are sent to requesters in lieu of meetings conducted in one of the other two formats described above
In reality, there were only 2 options as option 1 is off the table due to COVID.
I'm optimistic that the FDA recommended the WRO meeting because the questions CytoDyn has are straightforward and shouldn't require a back and forth conversation. Given how stretched out the FDAs resources must be at the moment, it would also make sense that they're reserving teleconferences/videoconferences for COVID related matters.
I don't see how Bruce's presence factored into the FDAs recommendation for a WRO (Written Response Only) Type A meeting.
https://www.fda.gov/media/109951/download
IV. MEETING FORMATS
There are three meeting formats: face to face, teleconference/videoconference, and WRO as follows:
(1)Face to face — Traditional face-to-face meetings are those in which the majority of attendees participate in person at the FDA
(2)Teleconference/Videoconference — Teleconferences/videoconferences are meetings in which the attendees participate from various remote locations via an audio (e.g., telephone) and/or video connection
(3)Written response only — WRO responses are sent to requesters in lieu of meetings conducted in one of the other two formats described above
In reality, there were only 2 options as option 1 is off the table due to COVID.
I'm optimistic that the FDA recommended the WRO meeting because the questions CytoDyn has are straightforward and shouldn't require a back and forth conversation. Given how stretched out the FDAs resources must be at the moment, it would also make sense that they're reserving teleconferences/videoconferences for COVID related matters.
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