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I'm not writing it off that easily in EU jay, BC are marketing there now and I'd be surprised if they aren't making progress. JMHO

Didn't know about Poland? Can also add Malaysia to that I believe. Others:

Already have CE-ivd mark for commercialisation in Europe.

A European MoH negotiation still ongoing as far as we are aware.

LTA with UNICEF for HCV kit in place as far as we are aware.

86 86 temporarily there and up we go, could be a good afternoon but wtfdik (all I do know is we ain't done with news flow yet and last couple of weeks have been good)

Yeah, we've seen good volume so far today and seen to be in buy zone right now

You'd also probably need to check if any applications had been withdrawn/removed to slightly complicate things

Hard to tell LordPaul, one list shows manufacturers who have applied, but is not regularly updated with approvals. Not sure how frequently new applications get added either. Another list is updated and contains approvals but does not show applications. You could try to go through comparing but I can't say I'm inclined to! (See a conversation between me and doozy yesterday)

According to the FDA e-mail those five were all updated ones rather than new. (My hunch is we are imminent now, but it'll come either way)

According to Twitter there's an FT article out about odx and GDR, anyone seen?

Yeah. I have observed they do update the one I linked after approval, but not the one we were talking about, so I'm ignoring the latter! Anyway, all I guess I was saying is that my observation is that timescale and their rate of approval is enough now that I would no longer want to bet AGAINST it coming through imminently, and have positioned accordingly

I don't trust that list. It doesn't seem to be regularly updated. The list here for example, shows that the thermofisher kit is approved

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular

04/09/2021 Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit
04/09/2021

Yet on the list you linked it still says not approved

Thermo Fisher Scientific, TaqPath™ COVID 19 High Throughput Combo Kit (also called "The Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit") Not FDA Authorized

They just don't seem all year to have been properly updating that list

Probably gonna get called out for this one, and not making a prediction, but I'm expecting more FDA approvals announced by Tues given recent rate of activity (and they were quiet last week on that front). Not to say GDR is definitely gonna be one of them, but I think it's at a fairly decent statistical probability now.

Agree grimshady, the positioning has really come together now on all products, and BC don't mess about so I fully expect there's movement behind the scenes there and not just in one jurisdiction

Good find Invest4theLT, hadn't seen those pages up before, look new?

Yeah, we will no doubt

No new FDA EUAs this week as far as I can tell, last reported ones were Fri 23rd. (There were some updated/reissued ones)

(Take your pick, either/all of: They've done ours this week and we'll find out Tues; they've given up and gone on 'vacation'; and failing that, the jokes old, now they're just taking the michael)

OK FDA, your turn now, time enough already. ICMR: 100% sensitivity, 100% specificity. Should be no excuses.

I really wouldn't bank on either of those assumptions

Cracking. Looks like over 9% of the stock traded today (unless I'm miscalculating that somehow?), and be interesting to see what we get late

Yeah, FDA will be working Monday and we won't. To state the obvious, it's nigh certain to come now and could be any time (slow as f though they always are)

Hey thanks trickymatters