Thursday, May 20, 2021 2:29:13 PM
Here's what a PDUFA date is, and how it can affect biotech stocks.
Jul 7, 2016 at 10:03AM
It's in the best interest of both pharmaceutical companies and patients to bring new drugs to the market as quickly as possible, which is why the Prescription Drug User Fee Act, or PDUFA, was established. Originally passed in 1992, PDUFA authorizes the FDA to collect fees from drug manufacturers to fund the drug approval process. PDUFA dates are deadlines by which the FDA must review new drug applications. The Prescription Drug User Fee Act typically calls for a period of 10 months to review such applications, though drugs that are deemed priority have a review period of six months.
If UEEC has gone through this process before over 3x the company keeps saying the same thing. I am not down playing the company at all its just being realistic. product - the best no questions. but they have no sales what so ever and the patents they have are on an expiring time frame. the stock price has declined from its highs and if not approved this time around it will drop again. im taking a guess here that people are in restricted stock. if so do your research on how long the shares take to get released. shocking what you would find out if this does go to 5
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