While the company was disappointed by the rejection, Applied CEO Soshana Shendelman said in a statement that it plans to work with the FDA to address concerns in the CRL and determine an expeditious path forward for govorestat
Whether youve met your annual deductible
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While the FDA includes a boxed warning about potential thyroid cancer risk, clinical trials involving over 10,000 participants have not demonstrated increased thyroid nodule or cancer incidence in humans
[PMC free article: PMC232521] [PubMed: 9343431] 9
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