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Japes1

05/22/15 12:15 AM

#3836 RE: Seel #3834

My only point was I disagreed with your position about the trial-- "Here's the thing about the trial - the patients in the trial all fit the trials criteria..."
I don't think that's true. They were using Phase 1 and 2 to find the criteria cumulatively.
I haven't bookmarked everything I've read, but if you search through SA and other sites, there is someone claiming they were in the trial and that they did not fit the criteria.

Among other things they did not have the type of ALS of the participants. He had FALS. He claims he was denied the trial because he did not fit the criteria, and was later called and asked to participate.
There is another patient who did not fit the criteria, he was in last stages of later diagnosis. They accepted him; he initally got better, but then, did not. He had few viable neurons left. He died from the disease, and now his wife is a speaker on various news events re ALS.

To me that says, the criteria was mixed and rightly so. Finding your target for the PH. 3 is key. Until there was a Ph.1, they didn't know bulbar patients would not respond. Until the Phase 2, they were unaware that grip strength was an issue.
The excerpt from the Feldman paper is just that. It isn't the entire article, simply one page. Hopefully, it will elucidate when published.