FDA issued third Complete Response Letter (CRL) on March 17, 2026. CRL cited lack of substantial evidence of efficacy — inconsistency of study results raises serious concerns about reliability. PDUFA was extended from Dec 2025 to March 16, 2026 after FDA requested clinical study report. No safety or manufacturing concerns identified. Second CRL was Nov 2023.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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