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Asked concerning the reasoning behind the formal rejection of Lykos’s application shipped on Aug. nine, an File.D.A. spokeswoman explained to me that significant limits to the data “protect against the company from concluding that this drug is Protected and efficient.
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Lykos has mentioned that it options to fulfill With all the F.D.A. in the coming months to handle the company’s worries and take a look at to avoid having to conduct Yet another high priced scientific demo.
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