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Hi All, have been researching MHRA approval this evening to try and get a view on how long it usually takes. Its pretty vague on other RNS announcements from other companies that have gone through the process, but longest i could find was 60ish days but most looked to be about 30 days. This also chimes with some of the info on the MHRA gov website.
However, i also noted that some have been 'fast tracked' inside 14 days.
If i was a betting man, which i am as i've bet on ODX, i'd say we'll be getting confirmation of MHRA approval either this week or next. I cant see us waiting much longer than that.
JUst my opinion DYOR. Would be happy if anyone else has seen anything more concrete regards MHRA approval timescales.
This is where the government backing of the RTC will help with fast tracking
Yeah, consortium or not though i'd say anything covid testing related will be pushed through quickly.
While
Thanks for the post but it just about sums up the incompetence with the whole system in this gb land. If we were American company we would now have already been cleared. I'm afraid I have a vision of a report dat on some lazy fat slobs desk doing nothing .hope I'm wrong
The RTC test and the process has been refined for 6 months, everything I’ve read suggests it’s about as perfect as what can be achieved.
Being provided to MHRA alongside a successfully carried out a 2000 patient trial at Ulster university. I cannot see it being much beyond a ticky box exercise personally.
It’s almost as though the updated guidance today was written about the RTC test. It’s been about what 15 days since submission? Any day now, I thought at best Monday this week.. We might find our answer at 7am tomorrow..
I think you touch on a good point here. Time is against us and we can’t let perfect be the enemy of the good eg waiting years for the prefect test when we have a 99% one developed in 6 months. Same with the saliva antigen test we need the best test we have rolled out as soon as possible and this will be a factor in MHRA approval. Once the Odx test is fully approved R&D isn’t going to just stop, they eg Abingdon, will be working on Mark 2 test and so on for years to come. Hopefully we will have a large chunk of the market by the time the 100% accurate test arrives
Unfortunately it is plausible that approval is being withheld for policy reasons. With our government worried about compliance / adherence to its newly announced restrictions, perhaps they are concerned that people will self-test and modify their behaviour if the test shows they have antibodies. Furthermore, home testing doesn’t result in stats collection.
We may see “community use” eg via GP’s and formal healthcare settings before we see approval for home testing.