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FeMike

05/07/24 2:08 PM

#689473 RE: learningcurve2020 #689461

Yeah, but the point is you shouldn't have to. NWBO should've spelled it out



Did you even read the PIP press release that NWBO published?

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.....The Company's approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.



How can they spell it out any more clearly than that? The hell else do they need to tell you? If you can't figure out from that statement that the pediatric trial doesn't have to start prior to approval, you need more help than NWBO can give you.