Found one in Scientific advice and protocol assistance Adopted during the CHMP meeting 13 – 16 September 2021.
...not so sure it has anything to do with ANP.....
Definition of Protocol Assistance:
Protocol assistance is the special form of scientific advice available for developers of designated orphan medicines for rare diseases.In addition to scientific advice, developers of orphan medicines can receive answers to questions relating to the criteria for authorisation of an orphan medicine. These include:the demonstration of significant benefit within the scope of the designated orphan indication;similarity or clinical superiority over other medicines. This is relevant if other orphan medicinal products exist that might be similar to the product concerned and which have market exclusivity in the same indication.
https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-protocol-assistance-adopted-during-chmp-meeting-13-16-september-2021_en.pdf
Where others have failed will Atl1102 succeed ?, page-345
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