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The Complete Response Letter signifies regulatory hurdles for TLX250-CDx. Previous CRLs have negatively impacted stock performance historically.
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Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding TLX250-CDx. The CRL highlights deficiencies in the Chemistry, Manufacturing, and Controls package. Remediation is required for third-party manufacturing before resubmission to the FDA. Zircaix's approval is crucial as it would be the first PET scan drug for kidney cancer. Current stock price is down 13.18% following the news.
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