Step #3: Look For Advisory Committee Meeting Information
In most cases, before the PDUFA date, there’s another very important event that takes place. The event is known as the FDA Advisory Committee Meeting.
The FDA has several different Advisory Committees that are made up of experts in specific areas of medicine. While Advisory Committees don’t make approval or denial decisions, their opinions are held very highly by those that make these decisions.
There is no specific time fram of when Advisory Committee Meetings are held, but in most cases, you will see them. So, before making a decision to invest or not invest in a stock with a coming PDUFA date, it’s a good idea to do a search to see if an Advisory Committee Meeting is scheduled or has already taken place.
At these meetings, the Advisory Committee will hold a vote for or against the approval of the new drug or biologic agent. I’ve found that when advisory committees have landslide votes for approval, there’s a good chance that approval will take place. However, if there is a mixed vote or a vote to decline the Application, then a rejection will generally be the result.
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