Why the late addition of an Italian site to the MF study?

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Why the late addition of an Italian site to the MF study?

Post by biopearl123 » Sun Sep 15, 2019 2:44 am

Why was there a late addition of an Italian site to the MF trial (which was no longer enrolling patients)? Well one might speculate that the "outlier" study: "18.Palandri F, Elli EM, Polverelli N, Bonifacio M, Benevolo G, Abruzzese E, Bergamaschi M, Tieghi A, Iurlo A, Crugnola M, Cavazzini F, Binotto G, Isidori A, Sgherza N, Bosi C, Latagliata R, Auteri G, Scaffidi L, Cattaneo D, Catani L, Krampera M, Vitolo U, Aversa F, Lemoli RM, Cuneo A, Semenzato G, Foa R, Raimondo FD, Cavo M, Bartoletti D, Vianelli N, Breccia M, Palumbo GA. Outcome of Patients with Myelofibrosis after Ruxolitinib Failure: Role of Disease Status and Treatment Strategies in 214 Patients. Blood. 2018;132:4277."

This study showed RWD quite different from the 12 to 14 month ASH presentation might have raised some eyebrows with its 22.7 month MOS using RWD. Could it be that the late addition of the Italian site was an attempt to apply the same statistical tools used in the ASH presentation to this data from Italy? Perhaps to try to explain this discrepancy? It could also explain the delay in presenting to the FDA as this surely would have been a problem for Geron if left unexplained and unexplored while they put their new statistician to work on explaining these data. Pure speculation on my part. Any thought? bp

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