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FDA Predictor

Upcoming FDA decisions on real drugs. Approval estimates appear only from a released model, always with its version, range and reasons.

Model status: not released.

The FDA approval model is being tested on past FDA decisions. Estimates appear only after it passes all nine release checks and a second admin approves it, so P(Approve), the 95% CI and Confidence read “Not released” for every drug. How estimates work

No validated model has passed the release gates.

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FDA Approval Predictions

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Upcoming PDUFA dates with the drug's horizon, CT-VCA score and the model columns
DrugHorizonCT-VCAP(Approve)95% CIPDUFAConfidence
CemdisiranREGN FiledNo published CT-VCA scoreNot released: no approval estimate is shownNot released: no confidence interval is shown29 days left in the periodNot released: no confidence level is shown
BXCL501Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetBTAIQ Phase 3No published CT-VCA scoreNot released: no approval estimate is shownNot released: no confidence interval is shown13 days to goNot released: no confidence level is shown
IvonescimabNot yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetSMMT Phase 3No published CT-VCA scoreNot released: no approval estimate is shownNot released: no confidence interval is shown13 days to goNot released: no confidence level is shown
PovetaciceptVRTX FiledNo published CT-VCA scoreNot released: no approval estimate is shownNot released: no confidence interval is shown29 days to goNot released: no confidence level is shown

Dates come from company and FDA disclosures and can change. Confidence levels arrive with a released model (P-11). Nothing here is investment advice.

Your plan shows the next 30 days. Pro shows every date.

Open the PDUFA Calendar · See past FDA decisions