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In its Complete Response Letter, FDA said results from the Phase III ROMAN trial, in combination with the GT-201 trial, were not sufficiently persuasive to establish substantial evidence of avasopasems effectiveness and safety in reducing these mouth sores

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Men are often embarrassed or in denial about penis cancer and so only seek treatment at a late stage

Reference #18.900c0317.1784901794.d6e63373

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Early human trials identified effective daily doses in the range of 12 mg for tanning, with conservative protocols starting lower to minimize side effects such as nausea and flushing [2] [3]