Mereo BioPharma Group plc (Mereo) (MREO) Social Stream
Featured Post From StockTwits About MREO
$MREO I hope we are close to an announcement on Setrusumab. It would be great if they got the following from FDA…Spiceman63, published August 13, 2021
The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children aged 18 years or younger and fewer than 200,000 people in the United States. If a Biologics License Application (“BLA”) in the United States for setrusumab is approved, Mereo may be eligible to receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred to other companies for their programs, as has been done by other voucher recipients.
“Receiving Rare Pediatric Disease designation from the FDA highlights the significant unmet medical need facing children with OI and underscores the potential of setrusumab to become the first approved treatment option specifically for these patients,” said Dr. Denise Scots-Knight