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aikifredicist

12/07/12 6:39 PM

#103930 RE: dia76ca #103928

From recent postings:

You may get your wish , i.e. much faster approvals.

From NYTimes:
"Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses"
http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?nl=todaysheadlines&emc=edit_th_20121204&_r=0


Is the conventional Phase III pathway appropriate for a potentially revolutionary drug like Bavi?
Once again I recommend viewing this week's BioCentury webcast:
http://www.biocenturytv.com/player/2000894425001/2003420183001
. The new FDA Breakthrough Pathway seems taylor made for a drug like Bavi.