I would imagine through the EMA i would say yes
With regards to phases i would imagine if a company wanted to do a short sharp low number trial for a new indication they could call that a ph2 then dependent on the market and the rarity of the disease then they could well follow in the footsteps of our DMD trial over 12month 2b yes and possibly of to market under similar circumstances
No not because of our pre clinical data
Because of our results in our ph2 in RRMs our pre clinical has been classed as not up to scratch by the FDA for no other reason than length of study
With regards to the FDA we still have to clear up the partial hold @25mg which could be put to rest with the 9 month Tox study and i have just covered my thoughts on this on my last post
Hope this helps
Good luck to us all see what tomorrow brings
See how we go
I would imagine through the EMA i would say yes With regards to...
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