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(i) ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, Good Manufacturing Practice (“GMP”) deficiencies at its third-party contract manufacturing organizations (“CMOs”) for the antibody cytokine fusion protein N-803, commercially referred to as “Anktiva”; (ii) one or more of the Company’s third-party CMOs for Anktiva did in fact suffer from GMP deficiencies; (iii) the foregoing deficiencies was likely to cause the FDA to reject the Anktiva Biologics License Application (“BLA”) in its present form; (iv) accordingly, the Company overstated the regulatory approval prospects for the Anktiva BLA; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
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