Replies to post #2416 on BrainStorm Cell Therapeutics Inc (BCLI)

[Lorcan458]

Look in more depth at the results. Different markers diminish at different rates. You're best bet would be to ask the most knowledgable medicial or scientific person you know to look at the data. We amatuers are guessing. Guessing is not the best investment strategy.

Phase 2 was meant to show safety. Although there were measurable medical improvements, a single dose is not how the treatment will be administered when looking for efficacy. That's happening right now in phase 3. If more people get up and walk away from wheelchairs, we've made a great investment. If there is a previously unknown safety issue, severe enough side effect or a lack of efficacy, we made an economically bad investment, but at least it was an investment to bring hope to those suffering with ALS. I'd rather lose money on this than on something like bitcoin.

[Spideyboy]

The phase II data shows clinical efficacy that lasts 4 weeks.

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.

responders were defined using a very high threshold of 100% improvement in the slope post-treatment compared to the pre-treatment slope, meaning a subject needed to have stable disease or improve to be defined as a responder.

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.