(Total Views: 835)
Posted On: 09/06/2020 6:28:06 PM
Post# of 153913
FDA said no HIV Type A meeting. Then FDA provided written answers to questions. Then FDA scheduled a type A meeting.
How does this sequence of events make sense?
Does the FDA routinely schedule a type A meeting after saying "No"?
How about the FDA scheduling a type A meeting almost immediately after providing written responses?
Did this scenario happen: 1) FDA provides written responses to CYDY questions, 2) CYDY reads the written responses and then calls FDA and says, "Well can we have a type A meeting anyways", and the FDA immediately says "Sure".
That scenario doesn't make a lot of sense.
CYDY never actually states that CYDY asked for the type A meeting subsequent to the receipt of the FDA written answers.
Maybe the FDA scheduled the type A meeting upon their own initiative?
Perhaps most likely is that something else precipitated the Tuesday FDA meeting?
How does this sequence of events make sense?
Does the FDA routinely schedule a type A meeting after saying "No"?
How about the FDA scheduling a type A meeting almost immediately after providing written responses?
Did this scenario happen: 1) FDA provides written responses to CYDY questions, 2) CYDY reads the written responses and then calls FDA and says, "Well can we have a type A meeting anyways", and the FDA immediately says "Sure".
That scenario doesn't make a lot of sense.
CYDY never actually states that CYDY asked for the type A meeting subsequent to the receipt of the FDA written answers.
Maybe the FDA scheduled the type A meeting upon their own initiative?
Perhaps most likely is that something else precipitated the Tuesday FDA meeting?
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