https://www.ema.europa.eu/en/documents/presentation/presentation-how-are-medicines-evaluated-european-medicines-agency-part-
1_en.pdfhttps://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medic
ines-
step-step
Did you know..?The assessment time may be reduced to 150 days instead of 210 days, if the medicine developer is granted accelerated assessment. This is possible for medicines considered of major interest for public health, for example those that target a condition for which there is no treatment option and that have the potential to address the unmet medical need.
As far as I know Itsa is confident that the EMA will give Atl1102 the green light…
Dmd is an unmet need… so we have got accelerated assessment….
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