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Currently, an exemption allows Australian compounding pharmacists to individually reproduce brandname drugs in times of shortage, meaning replica drugs are legal, but they are not subject to the same stringent safety checks as brandname pharmaceuticals

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Furthermore, Amylyx is actively engaging in discussions with the broader congenital HI community, including experts in the field, to develop a path forward based on promising Phase 2 study results conducted at Children's Hospital of Philadelphia

The recovery peptides (BPC-157, TB-500, GLOW/KLOW) are mostly animal-data hype with thin human evidence, no quality control on the gray market, and an automatic ban if you compete