The wikipedia explanation actually explains carefully how the voucher can be used in a number of ways, including boosting the valuation of the company. It makes sense as a deliberate attempt by the FDA to encourage drug development where there may be limited profitability.
Where it becomes interesting in the current situation is say a priority review leads to approval for Rex for congenital heart disease (doubling the capacity of the left ventricle of sick children, as highlighted at the AGM, is unequivocally impressive) the voucher then gets “repurposed” by the company by its paying the fee required to expedite a review for Rex in end stage LVAD patients. That gets even more interesting as that substantially increases the value of Rex even before a confirmatory Phase 3 needs to happen for congestive heart failure, as it could already be an approved product in use in both kids and adults for different diseases.
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- $100 Million Priority Review FDA Voucher
$100 Million Priority Review FDA Voucher, page-23
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