RE: BC Collaboration17 Sep 2020 11:42
BigAl, it suggests that BC/GDR are providing a 'system'. Although each will have separate regulatory approvals which will allow it to be used in certain territories like the US, India, EU, there may be some countries that will want to run their own validation trials on the combined system and/or some where additional approvals may be needed. An example might be China which doesn't accept CE or FDA. I think they are just being ultra cautious in their wording.