Genmab — Februar 2013
-
The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a Breakthrough Therapy. FDA is in the process of developing guidance related to this designation. Until guidance is developed, requests for Breakthrough Therapy designation should follow the criteria outlined below
-
-
tak!
-
60 dage efter submission. Ikke lang tid
-
Daratumumab passer som fod i hose til det program!
-
Hvis man sammenholder det med hvad Paul Richardson sagde på post ASH seminaret - nemlig at mulighed for hurtig godkendelse var "very real" såfremt data var gode - og det viste man i løbet af et halvt års tid, så passer det med "primary completion date"
-
Hvis ikke de søger, så gør jeg
-
hahaha mads. Genialt
-
der er godt smæk på idag 172k nu @gen.co
-
der bliver handlet igennem nu
-
316K
-
-
det er merill lynch, credit suisse på den ene side og ens og ddb på den anden side. Jeg tror det må være ATP der losser ud
-
Vedr. Solsens link. Så kan Ofa måske profitere af Ibrutinib. In combination with ofatumumab (Arzerra) on patients with chronic lymphocytic leukemia / small lymphocytic leukemia / prolymphocytic leukemia1 (CLL/SLL/ PLL1) and Richter transformation, results demonstrate that the combination was well-tolerated and highly active in patients with heavily pretreated relapsed/refractory CLL/SLL. The drug is described to have a rapid onset of response, low relapse rate, and favorable safety profile.http
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