Still waiting on an official statement from Novartis


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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
 




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
 








The statement will read something like this

"Novartis denies any wrongdoing"
"Novartis adheres to the highest standards of ethics & compliance"
"We will investigate this matter vigorously"
"Novartis conforms to industry standards"
"It depends on what the definition of Is Is"

Signed
Michael Cohen - New Novartis Ethics Spokesman
 








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
And it’s all coming back to me now..........:)
We make deals, go on a high, gossip about our own people with the people in this tiny one drug company, lay off our people because we are on a high with this new relationship and then it all crumbles. Let’s see the blossoming relationship now. Let’s charge ginormous amounts for meds and not care about good people that worked so hard for us.
 




What has happened to Novartis...is this the new normal where short sighted management and their implementation of weak/superficial business quality principles and quality organization all to meet short term goals/expectations