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Theme 2 encompassed side effects

In addition to a number of circumventricular organs [CVOs, e.g., median eminence (ME), area postrema (AP), subfornical organ, organum vasculosum of lamina terminalis], liraglutide was also observed in the hypothalamus [arcuate nucleus (ARC), paraventricular nucleus (PVN), supraoptic NTS, supraoptic decussation], which would have necessitated its uptake across the bloodbrain barrier

Some oncology sponsors moved Phase I dose-escalation studies to Australia which allows commercial manufacturing experience to transfer to TGA submissions and, via Project Orbis, potentially to the FDA specifically to avoid European CTR friction during the transition window

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