Posts tagged ‘SNTS’

UCERIS PDUFA Date Delay

This past week, the FDA told Santarus, Inc. that it was extending the review period for their ulcerative colitis drug UCERIS by 3 months.  The FDA extended the PDUFA Date to January 16, 2013 because they need more time to complete the review.

I usually don’t comment on share price or share price moves but I’m making an exception here.  The stock dipped on this news.  I can’t figure these things out.  It might not be negative news.  I don’t think the FDA has a mind set that says “This application won’t be approved but we need more time to review the bad data”.  I think the contrary holds.  If the FDA sees some merit in an application, it will take the extra time to support the approval.  There is still a PDUFA report card and extending the review period for a drug that will eventually be rejected doesn’t make sense.