Also, I am not really sold on this author knowing exactly what he is talking about. With comments like these:
"A successful ALS drug must show effects over a year or more so that short term results must be viewed with caution."
Where is he getting that? That is not true. So far the data on NurOwn suggests that the effects wear off after about 3 months or so, so they'll need to re-dose 3 or 4 times a year. That doesn't mean it isn't successful.
"Recently there have been two large trials in ALS involving Biogen’s dexpramipexole and Cytokinetic’s tirasemtiv. Neither drug was successful in showing a statistically significant improvement in ALSFRS-r in large randomized trials involving several hundred patients. Hence a statistically significant improvement in a 12 patient randomized trial would be stunning."
I think this is a meaningless statement. It wouldn't be stunning if the drug actually worked. Biogen and Cytokinetic's drug failed because it just didn't work. Especially if you are working with stem cells like BCLI and CUR, where you can't tell the cells not to do their job from the beginning.
I do agree with the points about not showing placebo results and that making this data difficult to interpret clearly. Why have a placebo arm if you aren't going to compare those who were treated with it? It brings the entirety of the data into question in my opinion.
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