Sponsors deposit the confirmatory trial budget in escrow at accelerated approval
To get an early approval, a company would set aside the money for the follow-up trial up front, so the trial cannot be quietly abandoned.
Confirmatory trials for accelerated approvals are often delayed or redesigned in ways that reduce their chance of a clear answer. The proposal is a financial escrow: at approval the sponsor deposits the estimated cost of the pre-agreed confirmatory trial with an independent trustee. The funds are released against enrolment and reporting milestones; if the sponsor defaults, the trustee funds an academic cooperative group to complete the trial. This complements, rather than replaces, an automatic sunset.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
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not linked directly; found by shared links- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares Accelerated approval, Regulatory divergence between regions, Incentives reward me-too drugs and marginal gains.
- IdeaProvisional prices for surrogate-endpoint approvals, reset when survival data arrive
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaEvery patient on an accelerated-approval drug enrolled in a registry until confirmation
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaMake post-progression sampling a condition of accelerated approval
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaReciprocal recognition of tumour-agnostic and rare-indication approvals across regulators
Shares Accelerated approval, Regulatory divergence between regions.
- IdeaNo accelerated approval for a combination without proof each part contributes
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
- ProductSerplulimab
Shares Regulatory divergence between regions, Incentives reward me-too drugs and marginal gains.
- IdeaTransferable priority vouchers for first-in-class drugs, with price conditions
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.