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brazen22

12/30/25 6:43 AM

#805410 RE: DrHigh #805139

Her logic doesn’t hold up. ‘150 days’ is a review-clock headline, not guaranteed calendar time—and we’re past the two-year anniversary since the MHRA submission, which tells you how ‘attractive’ that clock really is in practice. NWBO has spent millions on paid consultants (she even acknowledged this during the ASM); any regulatory consultant worth hiring would know that ‘150 days’ is best-case clock time, not a calendar promise—real timelines depend on dossier/CMC completeness and the questions that follow. The U.S. market is simply too large to ignore if the package was truly review-ready.