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Hatch-Waxman Patent Certification and the 30-Month Stay In seeking approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicants product or an approved method of using the product

Notably, carbonate (OC(O)O)-linked conjugates were highly susceptible to non-specific activation by physiological GSH, abolishing TrxR selectivity, highlighting a limitation of linker chemistry rather than the cyclic disulfide trigger

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This resulted in normalization of the tGSH:GSSG ratio, also known as the glutathione redox profile