メディシンバ応援の掲示板

>>23410

英語版では、各パイプラインについても詳細に紹介されていて日本語版でもそのまま掲載されたらかなりインパクトがあると思うんですが…
特に下記のような文言はぜひ入れてほしいものですね。

MN-166 (ibudilast): Phase 3 Ready in Progressive MS
Discussions Ongoing with Potential Partners

BARDA
FDA approval does not require human clinical studies for this indication
– FDA animal rule: development of medical countermeasures (MCMs) does not require human clinical trials to establish efficacy when these trials would not be ethical or feasible
– FDA can grant approval of a drug for a MCM indication based on well-controlled animal studies, when the results of these studies establish that the drug is reasonably likely to produce clinical benefit in humans