Biotek-snakken — Januar 2021
-
Orphazyme's Chief Medical Officer added:
"We have responded to all FDA information requests and submitted all outstanding information regarding the arimoclomol NDA for NPC. The Phase 3 trials for Amyotrophic Lateral Sclerosis and Inclusion Body Myositis remain on track for read-out in the first half of 2021 and we look forward to providing an update on our progress."
-
Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented:
"We believe Orphazyme has taken a number of important steps in 2020 ahead of potential commercialization of arimoclomol for NPC upon prospective FDA approval during the first half of 2021. Orphazyme has strengthened its financial position through a successful capital raise and subsequently established a strong U.S. footprint with new headquarters in Chicago and the addition of more than 30 employees.
-
In our view, Orphazyme is well positioned for future distribution and expanded engagement with providers, patients, regulators and the clinical testing community in 2021. It is also noteworthy that next year, Orphazyme may receive a response to its submission for regulatory approval in Europe for arimoclomol to treat NPC."
We will continue to provide updates that are relevant to our agreement with Orphazyme.
-
Reklame: https://www.proinvestor.com/donation
-
Tak @Fandel
-
Det spørger jeg til 30/12 19:49? Bioport har åbenbart valgt at lade sig garanterer til en egengodkendelse eftersom der henvises til CE godkendelse? Den hæftelse er meget kraftigere end en egentlig godkendelse - og lovlig hvis een er korrekt med ens produkt!
-
Nej du kan IKKE nøjes med en CE? Det er netop ideen med en CE mærkning! Du hæfter for alt hvad det IKKE passer i et CE setup => Normalt skrives der en overensstemmelse protokol for at begrænse sin hæftelse! Har Bioporto koblet sig selv på uden indskrækninger, det nægter jeg at tro på, hvis ikke samtidig sikker på akkrediteten er til stede!
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind