Declaring a complicated statistical analysis with a huge array of positive data as a "failure" is a little short-sighted. Its another CHF basically. Very positive results if a failure to find significance across the entire population - the reasons well explained (why they had candidates with over 5 years of degenerative disc disease in a trial defeats me). Another poorly applied/designed trial, but clear illustration of efficacy in key areas that will appeal to their partner. Yes they will require another trial, but that was the common expectation.
MSB has been oversold by disappointed hot money. The treatments clearly work just MSB has had bad luck with US authorities (NIH in ARDS trials and FDA in GvHD decision), in trials (CHF primary endpoint) and here arguably poor trial application (not unlike ARDS, but of their own doing in this case). Clearly in an ideal world the company should have nailed all this in Phase II. You know the next better designed Phase III trial for degenerative disc disease will blow through all endpoints. Another work in progress.
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