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J427 - Then how did NCYT get there approval so quickly. On average FDA are getting through 10 new approvals a week if you care to look on their website. It's a lot less than 6 months for approval of test, more like a few weeks. Long test periods are for new drugs for patients whereas GDR are a simple test. The FDA stuff will most likely approved for GDR in the next 2 - 4 weeks unless they have a problem with the test.
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?
so testing will be in demand for a long time
There won't be a vaccine that'smy thinking, its a cold type virus, we can only have temporary immunity from the current research, saying there will be a vaccine makes everyone feel better though.
It was reported on Bloomberg news in an interview that FDA require human trials before release and this takes 6 months. There is talk on fast tracking but the 6 months seems to be the earliest once human trails can start so that gives you some time scale for release to market.
BSi are advising us of 18 months for a medical device new product dossier review under the EU MDR, as stated not relevant here as diagnostics. JB
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.
I am in medical devices not diagnostics. Approvals in medical devices have been much slower due to COVID and in the EU the notified bodies being tied up with the new EU Regulations. You cannot really draw a comparison here where they should be pushing expedited reviews? JB
Just the man
Jimmy, do you have any tentative timelines of approvals, as in how long they take?
EU MDR no equivalency route anymore you have to have data and committed PMCF studies on your product. 510 k you can make an equivalency argument to claim safety and efficiency and get onto market. JB
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/
Take a look at the New EU MDR! CE marking now much harder than a 510k! Times have changed! JB
Yeah, the story of an AIM investors life.
He could have waited for the placing. They are still sat on a big pile of cash now, placing 100p above would have helped the share price, they would have met demand, why not do an Avacta and oversubscribe. Seems a missed opportunity, but so was me not selling a few weeks back.
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.
Do you know how long EUA takes?
Do we have any examples from the marketplace on how long others took?
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.