Thanks Shyaam We have been informed if we can replicate the 6...

Thanks Shyaam
We have been informed if we can replicate the 6 month study results over our 12 month ph2b that we are about to start then because of the rare disease and no other treatment out there then we will go to market

Of course there may well be follow up studies as we have been informed once the trial is ended then the treatment will be allowed to continue for an extended period

I am not sure how the ambulant boys are going to introduced we will hopefully find this out tomorrow

Also with regard to the FDA once more i have gone over this but by the time they have organised monkey trials etc etc i would be tempted to hold of on the FDA route and go to the FDA once the trial is completed along with the advocacy groups and try to get our drug to market through the FDA on the back of what will hopefully be a successful Ph2b and market approval through the EMA therefore reducing costs and having a global drug @ market across all continents through the one EMA trial

Any way that is a while of see what the immediate future holds first up

SEE HOW WE GO