Approval of the Paediatric Investigation Plan (PIP) by the Paediatric Committee (PDCO) of the European Medicine Agency (EMA) is required for the EU Marketing Authorization procedure for new medicines
Successful completion of the paediatric investigation plan procedure may make the way for achieving additional market exclusivity for the therapy used
A positive PDCO opinion is a significant regulatory milestone for the Company in the development and marketing approval of treatment of type 1 diabetes in children
“This is another important that brings us step closer to the initiation of key stages of clinical trials. We intend to continue our close cooperation with regulatory authorities to bring our treatment to the European market as soon as possible. A positive assessment of our trial plan means that the presented results within the Company’s R&D work are satisfactory for the EMA and the plan of further clinical trials in the treatment of type 1 diabetes in children is appropriate and its implementation in case of positive results will lead to approval of the therapy under a centralised procedure in the European Union. I would also like to note that in the fourth quarter of this year, we have a pre-IND meeting with the US FDA planned, where we will also consult a paediatric plan.”, said Prof. dr hab. n. med. Piotr Trzonkowski, President of the Management Board, co-founder and shareholder of PolTREG S.A.