Ah no...so, 008 is a P2 study. It was only ever meant to show a link between what could be happening in the joint and link this back to serum observations. It was also to study wet and dry biomarkers in regards to possible DMOAD connotations...its done this quite well albeit on very small numbers.
From here, this is a gateway to now having meaningful discussions with the authorities and chat about what might now be required to progress and obtain an endpoint(s) to eventually get a DMOAD onto our label. This will no doubt be incorporated into our main trial, possibly.
So ideally what we want is good WOMAC, good wet and dry biomarker observations along with structural improvements in 008. Yes we want that with little to no AE's if possible but it doesn't directly affect our chances of FDA approval as an example. It may do so indirectly IF there were serious AE's for instance.
FDA approval hinges on our 002 and later 003 trials all working well. 008 will be additive in terms of any changes (I suspect to 003) but lets see how those discussions play out before we get a better understanding of whats to change and how.
Hope that helps
DYOR
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