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The researcher, through fieldwork, interviews and visits across Slovakia, engaged with public, private, academic and non-governmental actors, learning the language and closely observing the local socio-economic environment

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Both oligomers and fibrils (especially the amyloid fibrils) are toxic to mitochondria (Lashuel et al., 2013)

It is not currently approved by the U.S

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"An alignment with this guideline would be highly desirable for pharmaceutical companies who develop products which are intended for registration in multiple markets covering both EU and US." Echoing other stakeholders, Xellia asked FDA to ensure it harmonizes terminologies and thresholds with EMA and ICH.