RE: FDA10 Jun 2021 21:19
Let's hope so drlong!
Re FDA, this isn't the only recall they've put out recently. Have to go back and look at the list, but I think some have been PCRs too. They don't like the older ones only based on one target as far as I can recall because they're missing variants.
We know the GDR one isn't, is picking up all variants so far as far as I'm aware, and has passed all other approvals and studies with flying colours. Based on that (and the company said as much in that presentation), there is no technical reason not to expect approval. Just when! Oh well, to my knowledge it's taken a year for others and we're about there. Frustrating as hell. Can't see it not coming now finally, but I don't work there!