The Heartfelt addressing..., page-10

vaxjopies, you therefore seem to think a non addictive anti-inflammatory option that shows superior safety & duration profile will get ignored in situation that DMOAD is not validated by PAR_008?

Lets not overlook the first gate we need to get through to proceed is safety rather than DM.

The purpose of PAR_008 is not well understood IMO as it won't conclusive endorse DM rather simply confirm prior clinical studies. The comprehensive nature of what PAR_008 is monitoring for should allow us to engage with the FDA on what they may allow as a suitable surrogate for DM designation (labelling). This narrowing of focus is what we should be looking to understand when we see initial read out of PAR_008 not whether it validates 50 years of clinical experience.