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MikeD

09/30/21 6:17 PM

#141136 RE: TempePhil #141135

Thank you TempePhil for your insights. T-20 days now. $RDGL
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HoneyBager

09/30/21 6:55 PM

#141138 RE: TempePhil #141135

To include the fact that the initial ide submit talk was delayed and using the days between initial target submission until now could have been steps 1.2.3
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Cameron12221

09/30/21 10:16 PM

#141140 RE: TempePhil #141135

Could the "mayo clinic protocol" be their "test plan"?
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DPep

10/01/21 2:13 PM

#141155 RE: TempePhil #141135

I think it is 30 days after receipt by FDA unless there needs to be some back and forth clarifications/additions.

Is there a formal date when the FDA had received the application?