RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases so, ONCY has had 8 years to work with EMA to understand what reduced trial they can run... it hasn't happened, because ONCY have yet to prove statsically that increased T-Cell clonality translates to clinical benefit, which would support its use as a biomarker, for a potential accelerated approval
NOTE how Matt even stated this year that the mBC trial will be traditional 2 arm study... i.e 450 patients or so, and 3-4 years...
Pathetic