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Number sleven

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Number sleven

Re: TalShu post# 436989

Thursday, 06/26/2025 7:05:05 PM

Thursday, June 26, 2025 7:05:05 PM

Post# of 448129
TalShu, No need to respond quickly. If we aren't required to apply for the SHTG label we should avoid that. In Europe we never applied for that indication. That prevents the generic companies from back dooring is in those markets. I will see what I can find on 505(b)(2) regulatory requirements.
Sleven,
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