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Number sleven

06/27/25 7:34 AM

#436994 RE: DAR53 #436993

DAR53, Patents aren't the issue. It's the indication granted by FDA. The NDA is how the generic companies weasel into the market with an ANDA. Read the post by Tatsumaki. According to him we don't need to apply for the SHTG indication for the new formulation. Assuming we intend to get approval for that product.
Sleven,