Seneca Biopharma Inc fka SNCA

[Japes1]

Actually according to the yet to be released JAMA opinion article by Eva Feldman&another scientist,the patients in all trials did not necessarily fit all the known criteria.

"Clinical Trials of Therapies for Amyotrophic Lateral Sclerosis: One Size Does Not Fit All" http://jamanetwork.com/collection.aspx?categoryid=5507

She suggests ALS is a disease of many sub-types and so eventually there may not be one treatment for all.

She mentions how in the trials 1&2 they tried to narrow types of participants in order to distinguish who could be helped. Someone in the last trial came out a few months back to state, for instance, that they were a last chance case and surprised they were taken to participate. This person had FALS a different strain, and particularly virulent.
She also uses a quote from the FDA which basically states, the markers for treatment in ALS are different from other trials. The importance is meeting endpoints (which they did) and...

"In response to a February 2013 hearing on drug treatment for ALS, the US FDA agreed that disease heterogeneity may affect clinical trial outcomes and that it would support methods that can identify these subgroups for a efficacy analysis. Furthermore, the US FDA indicated that it is open to alternative clinical trial end points and novel study designs that apply end points other than the more traditional survival and functional scale outcomes."