What is a PDUFA? im reading material about them but just cant seem to grasp the concept of it or really understand it. Is is someone able to help?
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PDUFA = Prescription Drug User Fee Act
When you have a drug that you want to test on people to get approval to sell it, you have to pay the FDA a fee to regulate your trial. If you don’t pay, the results don’t count and you don’t get to sell the drug.
But, the fee isn’t a secret. So, when you pay the fee and the FDA makes public “No_Lie5768 just paid a fee for a stage three trial on a drug”, that’s a tip to investors that you have a drug that’s promising enough that you plan to invest tons of money in a trial. It doesn’t tell them what the drug is or anything like that, but it does let them know you’re testing something new. They already know how long the process takes, so some investors start buying the company’s stock in hopes that the trial is successful and the company suddenly becomes a lot more valuable.
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