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.