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The CEO has already stated that the USA is one of the many key (high populous) markets the company is initially targeting. . We should therefore look out for FDA EUA being obtained very quickly indeed, especially as all the validation documentation is available from the completetd CE Mark approval. I expect to see FDA EUA for the GDR testl next week. When that arrives, the fuse paper on sales in the USA will have surely been lit.
@flyingmachine yep, I refresh this page everyday https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd ;-)
Just looking at NCYT it took approx 5 weeks from CE-mark to FDA approval and approx 7 weeks from CE-Mark to WHO EUL.
Does anyone have any info on whether we are looking at similar timeframes? Or are the above representative?
Presumably much quicker if commercial sales are expected in June!
There are plenty of other countries out there we can currently sell to, so don’t think sales are necessarily dependent on either of these approvals.
22nd May for GDR CE-IVD
FDA and WHO approvals may have been submitted contemporaneous to CE Mark, we know from the RNS that the CE Mark application was done in a manner that would support FDA and WHO approvals thus there may also be some time saving there
Judging from the NCYT RNS from 17th Feb, looks like they did similar.
For completeness, NCYT received FDA approval on 23rd March and WHO EUL on 8th April.
@burnshortrsburn you do know GDR should be recording sales in June right?
Well, similar timescales would give us FDA approval at end of June. Presumably the ‘June sales’ aren’t dependant on this approval. It might mean that US based orders might come in at the end of June in addition to other orders earlier in the month.
Scart just filter him, he's a self announced shorter that is also quite the racist if you take a look at this twitter....absolute scum
https://twitter.com/BurnShortrsBurn
@ben on your head so be it, he's gone :-)
If he takes some of the heat off me, I welcome his arrival!!
Sounds like he needs sectioning. Not even joking.
@magsy haha!
The product has been available for a week. Why would we take until July for news lol. Also why do you think 6-8 weeks for a key product in demand from the FDA. EU approval was three weeks. Why not knock on the door at AVCT or ODX and question their position as ODX have no validated product presently. Careful of agendas here. Especially this guy who openly stated he has a short open. Joker
These timescales are actual timescales from NCYTs covid test, so presumably the conditions are very similar here. Was looking for any evidence that we may get these approvals sooner (or later).
No need to interact with this loon
Sure but you’re assuming that our first sales are dependent on FDA approval. You don’t think that the first sales could come from a country that recognise the CE mark?
Don't bother mags, obviously done FA research on this or even listened to the 3 interview. filter
All he cares about is his short. Which contradicts his shortsburnrsburn name. Grade A ******.
the joker in questions said gdr wasnt worth anything 1 to 2 months ago, shame its risen from 30p since then
This guy is a short or someone who wants to get in lower. Seen it so many times. Filter bin.