Its a bigger question than you would think...my actual answer...

Its a bigger question than you would think...my actual answer could span a few pages ... no jokes

In summary, it depends.


If the data is really fairly awesome, then it prob could warrant some early discussions, my guess, only a guess, and back off with the streamers, balloons and firecrackers for now, is that the real fun will come with 6 month 008 data. That will show more of the durational aspect to DM and what happens to these little biomarkers over more time.

Again if the data is great, that will warrant some discussion with the FDA/EMA, it could go a few ways from here but the odds are that you'd need a cohort set up to look at the same but with more numbers in a clinical setting. Not crazy huge numbers but maybe 200 to 300 patients possibly a few more. Again its going to depend a lot on data and what's seen. That might be too early, maybe the FDA will want the full 12 months. But maybe thats (6 months) is early enough to get them to have more discussions? Depends again on the data, p value etc.

In actual fact , and again, only my opinion, you would really prob have to think the FDA would want a long durational study...yeah 3 to 5 years...

But before you give me a thumbs DOWN and not like me anymore..there are faster outcomes possible.

AA is one, but don't rely on it, don't assume its a given...but you know what, you get our drug selling in any capacity, off labelling is going to be the real deal. Word will get around and no matter whether the DM is on the label or not, it aint going to matter so much with the sheer volume uptake just for anyone thats in pain, can afford it without insurance (that comes later)..and we should be in a good place.

Positive (optimistic) thoughts here, must DYOR, I could be quite wrong.