Peter Starke, the agency’s lead medical reviewer.Īdditionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. “The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. The studies were “extremely small” and used statistical and research techniques no longer accepted by the agency, regulators said. The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine’s original approval.
“Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.” But after the episode, the deal was not finalized.“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. Instead, Moore agreed to a deal with Cuban, Daymond John, and Kevin O’Leary - $750,000 for 30 percent equity and 10 percent royalty. When FDNS was pitched on Shark Tank in 2011 (Mark Cuban’s first season), FDNS inventor Joe Moore turned down a $4 million offer for the whole company from Robert Herjavec. The latex-free, hypo-allergenic, non-visible product can be worn in the hot and cold and are one-size-fits-all. They can be worn over the nostrils for up to 24 hours and are self-cleaning “so they will not clog” and seal 100% of the nasal passage.
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