Thursday, January 18, 2018 2:09:23 AM
Your post referred to the overall data, including Fast and Slow progressors, where statistical efficacy was shown for 2 weeks.
https://prnewswire2-a.akamaihd.net/p/1893751/sp/189375100/thumbnail/entry_id/0_aey9hdpc/def_height/400/def_width/400/version/100012/type/1
But for the Phase III trial, Brainstorm stated they are only going to be recruiting Fast Progressors. These had 4 weeks statistical benefit
https://prnewswire2-a.akamaihd.net/p/1893751/sp/189375100/thumbnail/entry_id/0_r883qntw/def_height/400/def_width/400/version/100012/type/1
Brainstorm saw this and so is using only the fast progressors only for the Phase III to maximise the chances of Phase III success.
Also what you need to understand is that the '100% Improvement' in the ALSFRS-R slope effectively means no worsening of the situation or even potential improvement. So this means that in these Fast Progressors, NurOwn appears to be stopping the disease progression in it's tracks.
Also, clearly a treatment that would require a once every 2 weeks injection of new cells would not be seen as convenient or maybe even economically possible for patients. Thus also the benefit of the efficacy lasting 4 weeks. A nice once a month injection to potentially stop ALS dead in it's track in these fast progressors. That indeed will be a very fortunate treatment for these patients.
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