anonymous
Guest
anonymous
Guest
Thunderstorms tonight over Basel HQ, literally and figuratively...
Spot on ... higher ups do stupid things the grunts pay the price ... grunts have to listen to mds talk about bad press, spin it the way they say , more modules , trainings , a microscope we will be working under ... sucks
And it’s all coming back to me now..........so weak....silent Vas
Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma. The FDA supports the continued marketing and use of Zolgensma for patients with spinal muscular atrophy (SMA) less than 2 years of age. We maintain that the totality of the evidence demonstrating the product’s effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile. We remain steadfast that this important treatment remain available to pediatric patients with SMA less than 2 years of age.
Novartis stands behind Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy | Novartis