Grumpy-XL schreef op 26 april 2023 09:09:
Beleggers missen blijkbaar het nieuws over de toekenning van de PRV
www.federalregister.gov/documents/202..."Because Priority Review Vouchers (PRVs) may be sold, a secondary market for the vouchers has emerged, and their value has increased, although the market for the vouchers is limited.[29] Companies use the sale of PRVs to recoup expenses undertaken for drug research and development.[29] A 2015 Wall Street Journal article raised concerns about the sale of these vouchers, given that they "require the FDA to shorten its decision deadline to six months from the standard 10 months—potentially giving companies an extra four months' worth of sales," but also noted that a voucher is not a guarantee of FDA approval for a drug.[30]
In 2014, Regeneron Pharmaceuticals and Sanofi purchased a PRV that BioMarin had won for a recent rare disease drug approval for $67.5 million; the voucher cut four months off the regulatory review time for alirocumab and was part of their strategy to beat Amgen to market with the first approval of a PCSK9 inhibitor.[30][31][32] In 2015, Retrophin sold a PRV to Sanofi for around $245 million, and later the same year, United Therapeutics Corp. sold a PRV for a drug for a rare pediatric disease to AbbVie Inc. for $350 million.[33] In 2016–2018, the value of a voucher ranged from $125 million to $200 million, down from its peak in 2015.[34]"