RE: Application for Pediatric Rare Disease Designation9 Nov 2023 08:22
Hello Max,
It is up to the company to decide if they want to submit an RPD designation before they request a priority review voucher within their drug application. Submitting and having an RPD designation is not required before submitting a voucher request, however, many sponsors receive their designation before requesting a voucher.
The RPD designation request is reviewed and processed under the Office of Orphan Products Development and the Priority Review Voucher program is under the review division CDER or CBER.
Tomorrow @JenConnellyMD will be giving her 6th presentation in 4 months at @SNOSSA1. This is her 1st international invitation to present how oral gallium maltolate is being used to combat GBM in @IQAI_IB's sponsored ph 1 clinical trial being conducted at @MCWCancerCenter.
On 29 September 2023, the percentage of voting rights held by Free Association Books Limited dropped below 11%. TR1 was reporting below 11 % although they fell below 10%