There was a lot of material I liked in that interview.
The highlight for me is Paul impressing upon the pivot from merely a Pain and Function with safety profile to not only addition of duration BUT MRI observations.
True, a separate and focused DM trial would probably be required later on but it's the broadening of the label to include language like 'may assist in regeneration'....'signs of regrowth in joint structure'...'possible stabilisation of the disease course'....that will add incredible value to what we have.
If we don't get this value directly (ie charging more as this is now a DM product, we will get it as an off label. Doc's will understand this is so much more than mere pain and function and the label will potentially have these supportive words.
The MRI observations in 008 were profound. After only 6 months. What will our Phase 3 show at 6 and 12 m when n is 195 odd instead of just 15 !!! Show me the P in that case. It will be extraordinarily low I would guess.
Amazing
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