Novo: FDA-rejection could be caused by a lack of data
A heavy reduction in the number of patients in the final stages of the study forming the basis of FDA’s decision to reject Tresiba could be the reason why the drug appears to have a worse cardiovascular safety profile than its rival.
by Kresten Morten Munksgaard
When the number of patients drop statistical uncertainty goes up and that might be the reason that Novo Nordisk failed to gain approval for its new insulin, Tresiba, in the US, according to several sources.
Allerede abonnent?Log ind her
Læs hele artiklen
Få adgang i 14 dage for 0 kr. Det kræver intet kreditkort, og du vil ikke overgå til et betalt abonnement efterfølgende.
Med din prøveperiode får du:
Få fuld adgang til dig og dine kollegaer
Start et gratis virksomhedsprøveabonnementRelaterede artikler
Novo: It’s time to make up lost ground
For abonnenter
Novo-CSO: It’s a setback, we have to admit it
For abonnenter
Analyst: It is a massive surprise
For abonnenter
