Member Info for Subtle

Long way to go yet but questions are:
Cost per device
Cost per diagnostic test

Dornod,
I'm with you on that, dreadful.
If you are still lucky to have hair, how many more greys have you all developed since 2010?

Wouldn't worry about that 3card, by the time we get the approval reindeer would have evolved with snow-shoe type feet and will be useless pulling carts. Will have to think of another way...

J427,
Was this for possible vaccines or diagnostic kits? Obvs two very different things in terms of Human trials and time-scales for validation.

On another point, have there been any definitive discussions of costs?

Beginning to feel this is another year to write off...come back next year when the snow thaws and we've enjoyed another winter market with frigging reindeer everywhere.
Mind you, a bit of good news so far this year, we didn't see much herring broth thrown, bonus.

Crumbs, there's no hope.
Good news about Huawei if anyone's following that one.

That answers that one then...GAH

Gloria,
Are you genuinely nuts or did you spell 50p wrong?

Jimmy,
I've no real experience with MDR only FDA (diagnostics) as CE was handled by a parent company, but interesting nonetheless. 10 months was the upper-end for us back then, 8 months at the earliest with a billion pages of paperwork, yes to draw a comparison with such differences in equipment and current situations is pointless.

Safy,
Kudos if they manage that but still knocking on September. I'd imagine the administration will have their hands full.

LB28,
That is true, but Approvals take an age and from experience, nowt will happen will September, unless Covid starts to ramp up, trumps regulation and is pushed through (pending a good validation in the US).

Jimmy,
Not quite, MDR is on par (if not quite) with FDA, but has narrowed the goal posts compared to CE MDD.
There's a nice write up here which explains the details
https://www.kolabtree.com/blog/medical-device-regulatory-compliance-fda-vs-eu-mdr/

LB28,
Not this one, I'm still holding out for the 50's by the end of the month.

Yeah, the story of an AIM investors life.

No idea, but research will need to be carried out to some degree by the authorities over yonder (as far as I can remember) as research here isn't always an accepted standard, however, this comes at a cost, the placing was a good move to fund this is nothing else.

Just for the record as I used to be partially involved in certification in the US for medical products, namely for 510(k).
CE marking is very easy to achieve, you can past this product through as long as it mildly compares to another (even a bag of cement), that's why there is so much Chinese carp on the market.
FDA on the other hand is a very different kettle of fish, it takes a lot of time and there much more stringent boxes to tick. It can take 10 months to pass products through, this time can only be reduced if there are comparable products in use that have already certified.

safy,

You mean the realists? Those who have called 50p for the past few weeks are in my opinion far less dangerous than those who live in neverland.

Those LTH's wishing for a return to 2.20 will probably not see it again, with production comes costs, 2.20 was a speculation spike and these are very rarely met again.
Surprised there wasn't a little bounce today but there you go, onwards to the 50's...

yes Safy with the inevitable bounce tomorrow before it continues to slide...traders perfect entry that

...because he/she will make 7+K profit tomorrow in one day before they sell on close.
Sorry to say it again but this IS going to the 50's.