) -- Let's add to the summer fun with a spur-of-the-moment FDA Drug Approval Contest.
Those who have participated in the past know the drill: Your challenge is to correctly predict the outcome of key FDA regulatory events. For this summer contest, the focus will be on four drug approval decisions and one advisory panel.
Here they are:
: FDA advisory panel for the cancer drug carfilzomib on June 20.
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: FDA approval decision for the weight-loss drug lorcaserin on June 27.
(VVUS - Get Report)
: FDA approval decision for the weight-loss drug Qnexa on July 20.
: FDA approval decision for the prescription fish-oil pill AMR101 on July 26.
: FDA approval decision for carfilzomib on July 27.
You have three outcomes to choose from for each drug-approval decision:
The big win, meaning the drug is approved and can be marketed for sale immediately.
Complete Response Letter (CRL):
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.
The FDA chooses to extend the drug's review time, i.e., pushes out the approval decision to a later date.
For the Onyx FDA panel on June 20, predict whether the vote will be positive (recommendation for approval) or negative (recommendation against approval).
To play in the contest, please submit your predictions for all five FDA events using the "Add Comment" button found at the top or bottom of this Web page.
IMPORTANT: All entries must be submitted by 6 am EDT on Monday, June 18.
--Written by Adam Feuerstein in Boston.
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