Jeg ser at LOA har økt fordi DNB tror at det kan holde med et utvidet fase 2 (pivotal phase 2) for godkjenning. Altså slippe fase 3, samme greia som jeg har nevnt i PCIB-tråden.
However, we believe that both the LOA of 15% from the general data and the c25% (c23% to
c27%), as indicated by the orphan drug oncology data, might be too conservative, as we have
started to see quite a few approvals based on pivotal Phase II data (as Nordic Nanovector
also expects for Betalutin). Hence, if it were to get the drug approved, based on the pivotal
Phase II data, one could claim it is in effect in Phase III rather than Phase II, taking the LOA
up to c44% for orphan non-oncology drugs (basically in line with the data from DiMasi of
c37%). Hence, we have updated our model and now include an LOA of c30%, up from c20%.