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Posted On: 08/22/2021 3:24:54 PM
Post# of 72446
In answer to “ timing and the last phone call” . Remember these are only my conjectures of how I would manage the probable situations.
Regards the last phone call. It is only another data field that must be completed. There may be many incomplete fields of data to be reconciled. If Leo’s last PR meant all the data is in , then that’s what it meant. There is an unanswered question lurking here and that is “ what percentage of data must be accounted for and accurate. For example the data field “patient died”. Would immediately gone to the FDA for discrete evaluation, while other data awaits evaluation. In short we don’t know. To you and I , it’s done when they say it’s done.
IMHO be patient, as the last thing we want is sloppy data going forward to the FDA
Regards the last phone call. It is only another data field that must be completed. There may be many incomplete fields of data to be reconciled. If Leo’s last PR meant all the data is in , then that’s what it meant. There is an unanswered question lurking here and that is “ what percentage of data must be accounted for and accurate. For example the data field “patient died”. Would immediately gone to the FDA for discrete evaluation, while other data awaits evaluation. In short we don’t know. To you and I , it’s done when they say it’s done.
IMHO be patient, as the last thing we want is sloppy data going forward to the FDA
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Ronald A Phillips
