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Tuesday, May 07, 2024 4:56:07 PM
>>The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.
>>Under applicable UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to pediatric 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.
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