Discover and read the best of Twitter Threads about #nurown
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Today, we are pleased to share an important development in our efforts to deliver hope for those living with #ALS. We owe it to them to do everything in our power to provide access to promising therapies as quickly as possible because they don’t have time to wait. 🧵
The continued analysis and the feedback received from the many scientific presentations of the Phase 3 data uncovered key insights that furthered our understanding of NurOwn's mechanism of action and potential as a treatment for ALS.
After carefully considering these learnings, the totality of the evidence from NurOwn’s clinical studies, and the feedback received from key opinion leaders and the broader ALS community, we will submit a Biologics License Application to @US_FDA.
As a physician, I support the FDA's role in protecting patients from adverse events, ensuring safety & efficacy.
As a physician living with #ALS, I've recognized there must be different regulatory flexibility for untreatable lethal diseases.
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As a physician living with #ALS, I've recognized there must be different regulatory flexibility for untreatable lethal diseases.
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As a physician who was denied access to clinical trials for 8 yrs, I have been #DyingWaiting for some drug, any drug, with some efficacy to be approved.
I have been horrified by the FDA's regulatory rigidity & inhumanity toward the ALS community.
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I have been horrified by the FDA's regulatory rigidity & inhumanity toward the ALS community.
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After multiple meetings, a new #ALS Guidance Document in 2019, and a flawed subjective tool to evaluate efficacy as a trial endpoint, the FDA has refused to honor its promise to exercise regulatory flexibility in recognition of the "critical unmet need."
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@SteveFDA I am 61 years old & was diagnosed with ALS on February 14, 2020. I had always been healthy & led a healthy lifestyle. No drugs, no smoking & drink alcohol only socially. I have been robbed of my retirement after working for 45 years & my many plans for my golden yrs.
@SteveFDA I was going to get on a clinical trial immediately upon my diagnosis, but because of the Covid-19, it was put on hold, and is still on hold. Since that time, I have become very weak and unstable & my voice has been affected.
@SteveFDA ALS can strike anyone, at any time. It could strike you, or a family member. I never dreamed I would be struck with such a horrific & debilitating disease before I was able to enjoy my retirement, which I have been looking so forward to.
