Nice Sum Zaskar
just to add to your discussion...
Daratumumab, a "non orphan-drug", received "Breakthrough therapy destination" by the USFDA while in phase 1/2 (May 2013).
Janssen (Sub of J&J) made a potential billion $ deal with Genmab during 2012 while Daratumumab was still in phase 1/2.
http://www.firstwordpharma.com/node/1013741#axzz2l5ccGSt8
http://www.onclive.com/web-exclusives/Breakthrough-Designation-Granted-to-Daratumumab-for-Double-Refractory-Multiple-Myeloma
time for a reasonable discussion, page-2
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