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Table 3 Development stage of the OMPs discussed in MoCA meetings

From: Patients, payers and developers of Orphan Medicinal Products: lessons learned from 10 years’ multi-stakeholder dialogue on improving access in Europe via MoCA

Status at first contact

Number

Status as of 20 Feb. 2022

Pre- clinical stage

3

2 in development, 1 terminated

Phase 1 or combined Phase 1 and 2

4

1 in Phase 3, 1 authorised, 2 terminated

Phase 2

4

1 authorised, 1 in Phase 3, 2 terminated

Phase 3

7

3 authorised, 1 under evaluation by EMA, 2 in Phase 3, 1 terminated

Marketing authorisation application submitted

2

Both authorised

Already authorised in the EU

3

1 withdrawn, 1 off-patent, 1 marketed but not orphan