RE: FDA Round Table29 Nov 2020 21:30
No problem ZB. As well as the points you highlight, I found it interesting that on 4/11 the FDA replied as follows re timelines for getting some form of home test authorised;
“I can't give you any timeline on that unfortunately, because that is dependent on developers submitting those EUA requests and making sure that they are - that the data is there to support that use. But we have, you know, as we've talked about on this call previously, we are very interested in that and we have put out information about, you know our recommendations as well as our flexibility to consider different approaches. So we are looking forward to getting to that point.“
but by 17/11 the FDA had authorised its first home test.
Anyone who has been reading these transcripts over the last couple of months cannot have failed to spot the very particular priority that the FDA was placing on home testing, and that focus appears to have translated from a position on 4/11 of not even having an EUA application to a position, just 11 days later, of having authorised one!
So the message seems to be that if we can tick all the boxes then the possibility of a very short EUA process is very real. To me, having the ability to manufacture at scale in the US maybe the biggest limiting factor for us.