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hoffmann6383

09/18/22 10:49 AM

#514783 RE: exwannabe #514782

LOL, more nonsense. Read the last PR and the one prior. The MA is coming although some like to pretend it isn't.

The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.