FDA Supports Strategy Toward Registration for Azer-cel
Imugene Chief Executive Officer Leslie Chong said the FDA feedback provided important clarity as the Company advances toward a pivotal study “The alignment across dosing regimen, patient population selection, accelerated approval end point strategy and CMC readiness gives us confidence as we continue to design our pivotal study plans. Combined with our growing clinical data set, we believe azer-cel is well positioned to address highneed patient populations.”
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