BOT - Anything but charting, page-6072

it’s all explained in the webinar. They’ve already made the changes requested, it took all of two days. They now need to run a simple acceptance trial, meet with the FDA to make sure they’re ticking all the boxes, then hit resubmit. They’ve estimated that process will take three months to be completely confident. Then the FDA gets a mandated six months to respond. They could probably do it in a week, but they’re given six months by law and they’re a government organisation, so they’ll take their six months. It’s shit, but it’s what we’re dealing with.

The other point the BOT team have made is that the actual delay to commercialisation is much shorter, as they weren’t spinning up any sales resources until the new calendar year no matter what. So the actual impact becomes 3-6 months, not 9.