spot on Mozz! After all…… REMEMBER, We were knocked back on 505b2 repurposed pathway by the USA FDA because our results were so good, we were told to go find out why…. It looked like a disease modification result, not a pain and function result. Yes we were told to update outdated pharmakinetics in the dossier whilst we were at it too (a technicality) but the FDA took us down this road.
We are about to head back to them with excellent 6 month DMOAD data, but it’s the 12month data that is needed to prove DMOAD on the label. And proof can some from many angles…. At the LEAST Donna says ….. the joint being stabilised/preserved in term of degeneration decline 12 months out from the intervention.
We are most likely going to go back and show bone marrow oedema lesion reduction, cartilage preservation or improvement and reduction in bone spurring at 12 months with biomarker data and outcome measurements correlating.
What’s not to be excited at.
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