US/NA SITES 16/21

EU SITES 40/??

ROW SITES 0/15

① Regular ② Stats/Clin ③ SUP

SUCCESSFUL Ph 2

JDC(Joint Development Committee)

Eagle (Sponsor)

Evonik(IMP manufacture)

Inclin (Site Mgmt, Monitoring, TMF, Data Mgmt, Biostats, Drug Safety, IRB/EC Approvals, Regulatory Filings ex-US, Medical Writing)

Regional Clinical Operations

USA, CAN(InClin CRO)

GEO, SRB, ESP, CZE, SLK, LAT, HUN, ROM, GRE Novotech CRO

FRA, BEL, ZAFGalenus CRO

ARG, BRA, PER, COLResolution CRO

IQVIA(study sites payments)

Catalent (IMP pkg, kitting and distribution)

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