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De Keyser J, Sulter G, Luiten PG: Clinical trials with neuroprotective drugs in acute ischaemic stroke: are we doing the right thing

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The honest summary is that the biology is sound and the early signals are encouraging, but the proof most of us would want, consistent results in robust human trials, is still being built

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Its evidence base is genuinely strong for a trial-stage product two large Phase 3a randomized controlled trials plus a Phase 1b pharmacology study but it has not received marketing approval from any regulator, and its complete benefitrisk profile is still being evaluated