It's within the 45 days someone mentioned. Special thanks to oddone for posting what may be the equivalent to breakthrough designation...
To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
https://www.ema.europa.eu/en/human-regulatory...-medicines
To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
https://www.ema.europa.eu/en/human-regulatory...-medicines
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