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On the PDUFA date the FDA will either issue approval for marketing or issue a Complete Response Letter (CRL) - i.e. rejection letter. 2-4 months prior to PDUFA an advisory committee meets to discuss a drugs potential regarding the efficacy and/or safety. The committee will generally vote on the efficacy and safety of the product. The FDA is not bound by the committee decision, but usualy tends to follow the advice given by the committee when making its decision on or before the PDUFA date.
These PDUFA dates can greatly impact a share price. Historically if you look at past stocks and PDUFA dates, you can see the build prior to PDUFA and a spike. Follwing. these trends is an excellent trading startegy.
This board will be dedicated to sharing information on upcoming PDFUA dates.
As always do your own DD, and do not buy based on PDUFA dates listed here.
