the benefit-risk balance of the medicine is positi

Quote:

---

the benefit-risk balance of the medicine is positive;
it is likely that the applicant will be able to provide comprehensive data post-authorisation;
the medicine fulfils an unmet medical need;
the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.

---

Leronlimab in Alzheimer's, MASH, Long Covid, ME/CFS for starters. If by unmet medical need they mean a drug that could outperform anything else on the market without SAEs that list could be greatly expanded.