RE: Don't need an RNS29 Aug 2020 09:47
So we have some board Trial timelines that run into feb next year
The data from home trials is likely to be key in shortening the pivotal study , if the data massively agrees with the result of the hospital trial then it’s fast track to approval.
The downside to this is home recruiting in the U.K. is very slow due to the success of lockdown and quarantine.
So the question would be should SNG find a sponsor in a different country and extend the trial over there? This adds cost and complexity but needs to be weighed up over slow recruiting in the U.K. where we are controlling the virus but at cost to the economy.
Are we likely to need a placing to pay for these feb timelines, I know pi’s won’t like it but have to suck it up. What about ii’s ,
Whilst this info came from a us site , is it safe to say the trial rules are standardised across the international medical community? But approval is done on a regional basis , or to put it another way the regional reg bodies all work with the same results data