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The existence of this Phase 2 trial — even outside the US regulatory framework — is likely to be cited in PCAC proceedings as evidence that formal controlled evaluation is now underway, which is one of the factors considered in the four-factor PCAC analysis for clinical significance
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10.1038/onc.2015.20 [DOI] [PubMed] [Google Scholar] Gui Y., Yeganeh M., Ramanathan S., Leblanc C., Pomerleau V., Ferbeyre G., et al
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