Aight, I think I've figured out the statement:
"Increased composite outcomes of reduction in pain together with improvement in function in those with CLBP of shorter duration than 68 months, the median for the study; however, the composite outcomes of pain and function did not reach statistical significance across the entire study"
The below figure shows that Rexlemestrocel did not achieve significance at the 6-month time point.
Remembering that significance is determined as a p-value of >0.05. However, they achieved statistical significance at the 12-month and 24-month time points. Therefore "the composite outcomes of pain and function did not reach statistical significance across the entire study". This means that it met statistical significance at numerous points during its 24-month duration, but missed out at the 6-month mark by 0.009. This does not mean that the trial missed achieving the primary endpoint, and I am frankly astounded at the market's reaction.
It has been mentioned a hundred times, but again to have it here the primary outcome measure was:
"Treatment Success (composite responder analysis of low back pain Visual Analogue Scale (VAS) score, Oswestry Disability Index (ODI) score and no post-treatment interventions) [ Time Frame: 24 Months ]• To determine Overall Treatment Success of rexlemestrocel-L alone or rexlemestrocel-L+HA through 24 months based on a composite responder analysis"
The queries I have are around the ODI measures, as we have not seen these yet, but they do state:
"Increased composite outcomes of reduction in pain together with improvement in function in those with CLBP of shorter duration than 68 months"
So I'm not too worried about that data set.
The other concern regarding trial design is that there is no 'Hyaluronic Acid alone' control included. However, there is a wealth of data that shows that HA does not have a meaningful impact in this disease. I suspect this was discussed with the FDA during trial design and that the FDA agreed that a treatment group for HA alone would be unnecessary and redundant.
I am perplexed by the market reaction. This was always an indication that would have required a 2nd trial. However, with the significant reduction in opiate use it seems to have opened up a path to market that did not previously exist and fast track the process. These results are as good as we could have hoped for in my opinion, and I'm not sure what people who see this as a negative announcement would have wanted instead.
All this is my opinion and not investment advice.
Cheers,
Gang gang
(20min delay)