Genmab — Juli 2015
-
Janssen har sammen med BLA-ansøgningen anmodet om Priority Review-status. De amerikanske sundhedsmyndigheder, FDA, vil oplyse Janssen, hvorvidt der kan tildeles Priority Review-status inden for 60 kalenderdage, efter FDA begynder deres behandling af ansøgningen - altså per dags dato. Hvis FDA tildeler Priority Review-status, vil behandlingen af registreringsansøgningen ikke tage længere end maksimalt seks måneder.
-
Som tidligere nævnt tror jeg heller ikke, at nyheden er kursdrivende, fordi den var ventet, men jeg tror, den kan spille ind over BC, så de begynder shortscovering. Det går rigtig hurtigt lige nu. Det skule lige være den Grækenland, som endnu engang kan sætte en kæp i hjulet.
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind