avantiavanti schreef op 19 februari 2019 16:31:
Abbvie maakt haast en wil iig voorsprong in tijd proberen vast te houden. Ze voelen de bui aankomen. Deze prv zegt niks over de manier waarop NDA/FDA naar UPA data gaat kijken, alleen dat het 6 mnd duurt ipv 10 mnd.
pharmaphorum.com/news/spark-sells-pri...Under FDA rules, companies that develop a drug or biologic for a rare paediatric disease may qualify for a voucher, which can be redeemed for a priority review of a drug filing.
Priority reviews are usually reserved for badly-needed drugs for serious diseases, but the vouchers shave four months off the FDA review period for any drug, which could be worth millions of dollars in extra sales.
As the priority review vouchers (PRVs) can also be sold on to other companies, a second market for the vouchers has emerged.The highest price paid for a priority review is $350 million in August 2015, when United Therapeutics sold its voucher to AbbVie.