Post by
GoldenArm on Jun 29, 2021 1:12pm
Medexus gets Ok for Treosulfan in Canada
https://www.globenewswire.com/news-release/2021/06/28/2254293/0/en/Medexus-Receives-Notice-of-Compliance-to-Commercialize-Treosulfan-in-Canada.html
Ken d’Entremont, CEO, commented, “We are thrilled that Health Canada has approved treosulfan for full scale commercialization under the name Trecondyv®. We believe that there is an unmet need in Canada for this product and are happy to provide patients with this potentially curative treatment solution. We are also pleased that Health Canada has approved this drug for pediatric patients, which we believe is a reflection of the significant survival data that it has demonstrated in clinical trials. This Health Canada decision also gives us further confidence of attaining a positive outcome in the FDA’s upcoming decision in connection with our Prescription Drug User Fee Act (“PDUFA”) date on August 11th, which we hope will allow us to offer the product to patients in the United States.”
Comment by
GoldenArm on Jun 29, 2021 1:18pm
This is awesome news and should mean that the FDA approval is a done deal in August. Q4 (sept-dec) is going to be tremdous in terms of revenue.