BOSTON (TheStreet) -- Welcome to TheStreet's 2012 FDA Drug Approval Prediction Contest.
Your challenge: Correctly pick the approval decisions to be made by the U.S. Food and Drug Administration on 17 drugs between January and April. The person(s) with the most accurate predictions will receive a hearty congratulations, a mention in a future column and bragging rights as the best FDA drug-approval prognosticator of 2012.
I organized a similar FDA drug-approval contest in October 2010. Three winners emerged among 94 contestants, each correctly predicting 10 of 11 FDA decisions over the course of one month. This year's contest presents a tougher challenge -- more FDA drug-approval decisions spread out over four months.
You have three outcomes to choose from for each drug-approval decision:1. Full Approval: The big win, meaning the drug is approved and can be marketed for sale immediately. 2. Complete Response Letter: The FDA has some concerns or issues (incomplete data, labeling, risk management, etc.) that prevent the drug from being approved immediately. In other words, the drug's approval is rejected or delayed for some reason. 3. No Decision: The FDA chooses to extend the drug's review time, i.e., pushes out the approval decision to a later date. The 17 drugs up for FDA approval are listed below in chronological order. Use one of three choices for your prediction: Full Approval, Complete Response Letter or No Decision. To play TheStreet's FDA Drug Approval Prediction Contest, please copy the drug list, write in your approval prediction, and post your predictions using the "Add Comment" button found at the top or bottom of this Web page. You'll need to complete a short registration to post a comment -- make sure you include a valid email address so we can contact the winners. Please post your picks by Thursday, Jan. 26, at midnight. Entries received after the deadline are still eligible for the contest, but you won't get credit for drug-approval decisions already made by the time your entry was received. Good luck! Pending FDA Drug Approval Decisions: Jan. 27: Amylin Pharmaceuticals' (AMLN) Bydureon for diabetes.
Feb. 14: BioSante Pharmaceuticals' (BPAX) Bio-T-Gel for hypogonadism.
Feb. 17: Corcept Therapeutics' (CORT) Corlux for Cushing's sydrome.
Feb. 26: Columbia Labs' (CBRX) Prochieve for reduction of risk of preterm birth.
March 6: Discovery Labs' (DSCO) Surfaxin for respiratory distress syndrome.
March 6: Astex Pharmaceuticals' (ASTX) Dacogen for acute myeloid leukemia.
March 7: Neurogesx' (NGSX) Qutenza for HIV-related nerve pain.
March 8: Roche and Curis' (CRIS) vismodegib for basal cell carcinoma.
March 26: MAP Pharmaceuticals' (MAPP) Levadex for migraines.
March 27: Affymax's (AFFY) peginesatide for anemia due to chronic kidney disease.
March 28: Chelsea Therapeutics' (CHTP) Northera for orthostatic hypotension.
April 17: Vivus' (VVUS) Qnexa for obesity.
April 18: Vertex Pharmaceuticals' (VRTX) Kalydeco for cystic fibrosis
April 24: Cell Therapeutics' (CTIC) pixantrone for non-Hodgkin's lymphoma
April 26: Amgen's (AMGN) Xgeva for prevention or delay of spread of prostate cancer to bone.
April 27: Vivus' (VVUS) avanafil for erectile dysfunction. --Written by Adam Feuerstein in Boston.
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