Article

Regulator's view on the scientific and regulatory challenges in new mobility outcomes & PROs

2015-07-28

Abstract excerpt

The current focus from research based pharmaceutical companies is rather on cancer, not CNS. There are several reasons for this, e.g. problems with pre-clinical models, problems with dose-finding, large long-lasting trials, high failure rate, eventually leading to no return on investment. Are the regulatory requirements too high? Certainly not in Multiple Sclerosis, where we had 5 approvals since 2011 (Fingolimod,...

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Literature Corpus work: 439a6ca7-8d6d-5335-b39f-3b1314cf3a03
DOI: 10.7287/peerj.preprints.1270v1

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