Sierra PII Trials13 Aug 2018 21:56
Hi Stoney40
cracking post, i have not heard of that sort of trial approach before, as you say that would surely have an effect on the milestone payments that SAR sold receive,, if this is the case it should be part of an RNS i would have thought.
I would guess that the MHRA would approve that sort of trial just as readily as they would a traditional phase one two and three etc, there would just be more approval required at the outset i would presume?
I dont recall seeing any approval from the MHRA being visible to us but it must exist for the phase 1 to have started.
I am not sure that it is a cost effective way to conduct this open ended trail format as it could lead to all sorts of additional information being needed rather than the defined stages in the usual route.
All very good questions as you say, i for one would love to get some answers about this and the way it could pan out as this really effects the LTH point of view and timescales, well in my case it does.
Thanks for posting
KR