US anncts to come soon, hopefully from above.( thanks MM) The second one is a biggy.
Orphan Disease Designation The three main financial incentives attached to ODD are:
Tax credits up to 25% of qualified clinical trials costs
Waiver of FDA User Fees (~US$3m)
Eligibility to receive 7-years of marketing exclusivity
Rare Paediatric Disease Designation The main incentive attached to RPDD is that the drug sponsor becomes eligible to receive a Priority Review Voucher (PRV). The PRV is a transferable voucher that allows the bearer to receive priority review for any future product. Products with priority review can expect an FDA approval decision within 6 months of NDA submission, instead of the usual 10 months. The PRV is sellable and in the past some companies have sold them for amounts ranging from US$67 - $350 million.
PYC Price at posting:
15.5¢ Sentiment: Buy Disclosure: Held
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