Rilutek was approved, Nurown was not
- Thread starter jethro
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Nikki J
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At the MNDA meeting Professor Al Chalabi ( Kings London) said multiple studies showed Riluzole slowed progression by 38 percent. I had never heard this and I thought he misspoke so I asked at Mass general. She said yes ir is true. I do believe it helps me.
the story isn’t told with Nurown yet. They apparently just had a meeting with the FDA about manufacturing
www.prnewswire.com
the story isn’t told with Nurown yet. They apparently just had a meeting with the FDA about manufacturing
BrainStorm Announces Feedback from FDA Type-C Meeting on Future NurOwn® Manufacturing Plan
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced...
www.prnewswire.com
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The randomized trial data for riluzole are too old to generalize to today's patients, though investigators continue to try. The more modern studies of other therapies in which riluzole use and overall outcomes are recorded, cannot reflect random riluzole allocation since they randomized another therapy.
The sort of ongoing party line is that riluzole has a median survival benefit of 2-3 months, with no guarantees about which phase it prolongs -- early or late. No doubt a lot of the potential benefit rests on when it's started and what "subtype" of ALS the PALS has, as well as the use of therapies such as feeding tubes and BiPAPs.
NurOwn didn't hit their primary endpoint. That doesn't mean they're done, as many rx have emerged from those particular ashes. They and the FDA will discuss next steps: whether/how they can apply based on what they did hit, do more research with a different agreed primary endpoint, and/or tweak the "dose" again.
The sort of ongoing party line is that riluzole has a median survival benefit of 2-3 months, with no guarantees about which phase it prolongs -- early or late. No doubt a lot of the potential benefit rests on when it's started and what "subtype" of ALS the PALS has, as well as the use of therapies such as feeding tubes and BiPAPs.
NurOwn didn't hit their primary endpoint. That doesn't mean they're done, as many rx have emerged from those particular ashes. They and the FDA will discuss next steps: whether/how they can apply based on what they did hit, do more research with a different agreed primary endpoint, and/or tweak the "dose" again.
Texas Quilter
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My ALS Clinic in Houston said it only extended life by about 3 months. It made me nauseous so after a few months I stopped taking it.
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