File this underneath “So shut, but to this point.”
After a number of years of scuffling with regulatory hurdles to win approval for its uncommon illness drug, Stealth BioTherapeutics had anticipated the U.S. Meals and Drug Administration to reply on Tuesday to its advertising and marketing utility.
However late final week, the corporate acquired a letter saying there was a delay. Furthermore, the company didn’t point out when it might now full its evaluate for the drug, which is known as elamipretide and was developed to fight Barth syndrome. The uncommon sickness, which causes an enlarged coronary heart, muscle weak spot and a shortened life expectancy, afflicts almost 150 individuals within the U.S.
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