BOSTON (TheStreet) -- Back by popular demand, TheStreet's FDA Drug Approval Contest for 2013 -- with a few twists.
Your challenge: Correctly guess the outcome of the 12 regulatory events listed below. As a kicker to the contest, you're required to predict the outcome of a closely followed European drug approval decision, three FDA advisory panels and an accelerated approval meeting between a certain drug company and FDA officials.
Don't forget to answer the bonus question, as well.
To participate in the drug approval contest, please post your predictions to each of the 13 questions in the comments section under this story. Post your picks by Friday, March 8 at 4 pm ET. Entries posted after the deadline will not count, so don't be tardy with your picks. Enter now!As with my previous drug-approval contests, winners will be lauded for their intelligence on Twitter and in future columns. Losers will be mocked gently. Good luck! 1. Sarepta Therapeutics (SRPT): The FDA will grant the company's request to seek accelerated approval for eteplirsen. Yes or No? 2. Arena Pharmaceuticals (ARNA): The European Medicine Agency's CHMP will recommend approval of the weight-loss drug Belviq. Yes or No? 3. Titan Pharmaceuticals (TTNP): FDA advisory panel for Probuphine on March 21. Positive or negative vote? 4. A.P. Pharma (APPA): FDA approval decision for APF530 on March 27: Approve or Reject? 5. Biogen Idec (BIIB): FDA approval decision for BG-12 on March 28. Approve or Reject? 6. United Therapeutics (UTHR): FDA approval decision for oral Remodulin on March 29. Approve or Reject? 7. Sucampo Pharmaceuticals (SCMP): FDA approval decision for Amitiza on April 26. Approve or Reject? 8. Navidea Biopharmaceutials (NAVB): FDA approval decision for Lymphoseek on April 30. Approve or Reject? 9. Raptor Pharmaceuticals (RPTP): FDA approval decision for Procysbi on April 30. Approve or Reject? 10. Aveo Pharmaceuticals (AVEO): FDA advisory panel for Tivopath on May 2. Positive or negative vote? 11. Delcath Systems (DCTH): FDA advisory panel for ChemoSat (now known as Melblez) on May 2. Positive or negative vote? 12. Delcath Systems: FDA approval decision for Melblez on June 14. Approve or Reject? 13. Bonus question: Will the Ziopharm (ZIOP) phase III study of palifosfamide in sarcoma be successful (defined as meeting the PFS primary endpoint with statistical significance.) Yes or No? -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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