So the key point that seems to be generating so much confusion today is understanding the difference between a "key secondary endpoint" and a "standard secondary endpoint". A lot of the posts arguing against the trial results have been arguing from the point of view of the latter, when in fact the results released today are "key secondary endpoints" or related to these endpoints. Mortality rates related to cardiovascular death (those released today) have consistently been stated as key secondary endpoints. So what's the difference? I've done a little bit of research and found some information that may be useful:
“...at times, for planning purposes, a key endpoint such as mortality is called a secondary endpoint on expecting it to be a low yield endpoint. In this case, such a secondary endpoint is like a primary end-point and is sometimes called a key secondary endpoint. Its result, after proper multiplicity adjustments, if statistically significant in favor of the treatment, can provide a persuasive evidence of a clinical benefit of the study treatment.”
"Key secondary endpoints are those designated as most clinically important with pre-specified order for their analysis. P-values and confidence intervals for all other analyses are presented with NO adjustment for multiplicity. Nominal p-values and confidence intervals are consequently exploratory and cannot be used as a basis for efficacy claims in the product label if approved."
So based on all the research I've seen today, the reduction in CV death rates appear to be as good as the primary endpoint assuming that proper multiplicity adjustments have been performed on the results. If so, this will give us a strong case to go to the FDA with. We should also remember that mortality has been a frequent topic discussed between Mesoblast and the FDA during their meetings, as stated by SI during the conference call.
So there it is, these results may not be as bad as the market seems to be considering them to be.
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