The FDA guarantees a 60 day review timeline for a Rare...

The FDA guarantees a 60 day review timeline for a Rare Paediatric Disease Designation if the application is accompanied by an Orphan Drug Designation request and the applications are submitted within two weeks of one another. However, no RPD requests submitted after July 31 2020 were to be accepted by the FDA because of sunset clause provisions.

May Orfali said during the Investor Call on 12 August that both Rare Paediatric Disease Designation and Orphan Drug Designation requests were submitted by PYC on 31 July 2020. Therefore, if FDA meets its promised timeline, PYC should receive an answer on its Rare Paediatric Disease Designation request by 29 September (30 September Australian time).

FDA has a 120 day target review time for Orphan Disease Designation requests. The most recently published data shows that in the 9 months to June 2020, the FDA met its target review timeline 100% of the time. Therefore, it’s reasonable to expect a response on the Orphan Disease Designation request by the end of November at the very latest.

https://www.fda.gov/industry/develo...-disease-rpd-designation-and-voucher-programs

https://www.fda.gov/regulatory-info...re-pediatric-disease-priority-review-vouchers

https://www.accessdata.fda.gov/scri...nation-reviewed-completed-in-120-days-or-less