Its just a little bit more complicated than this Wytee.
The mean changes in VAS score are difficult to interpret because they fail to account for post treatment interventions.
It was this difficulty, as well as the problem of deriving clinically significance of changes at the subject level from group mean changes that caused MSB after the P2 trial to adopt the responder analysis.
The responder analysis accounts for both these factors.
If a subject get the cells but then requires further intervention this is (properly) counted as a failure. Because if the treatment had worked they wouldn’t be seeking further interventions.
The clinical significance of the change is set from X% change required at the subject level. Not the group mean level.
Now the responder analysis worked a treat in P2 … which is why MSB took this approach into P3. But it has failed to replicate.
In my mind the only two interesting questions are first what were the % number of responders (as defined in the primary outcome) in the treatment / placebo groups and second what were these % by the opioid group.
In other words did the primary endpoint miss by an inch or did it miss by a mile. If it missed by a mile … everything else is pretty well meaningless. If it was close … maybe there is a last ditch effort argument to be made.
But MSB doesn't report this.
In my opinion the failure to report on the primary outcome is non-compliant with the ASX code. People can read for themselves - Page 11 the section on primary outcomes and make their own mind up.
https://www.asx.com.au/documents/re...e_for_Reporting_by_Life_Science_Companies.pdf
Should you agree with me … you could let the ASX know.
https://www.asx.com.au/forms/customerFeedback.html#/
Its takes all of 5 minutes … mention reference number 02142132.
And @Davisite ….. no pressure but I expect you to pull your weight here! This is a great test case for fascinating debating point we have had together …. is the code worth the paper it is written on?
Its just a little bit more complicated than this Wytee. The mean...
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