Member Info for JimiHendrix

The Access Bio. Antigen test is on this other list here and shows all the details and documentation for the EUA approval... https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 ...not listed under Beckman Coulter but Access Bio is the company behind it.

Maestro, this FDA page here shows loads of EUA approved COVID tests... the most recent being 1st April 2021 (04-01-21 in US date format) 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

FDA typically takes about a year, so the more time goes by the higher the chances of it coming the next day :)

Nice to see Malaysia approval, this will start to have a domino effect IMO... the more validation the tests have from countries the quicker other countries will approve IMO.

What DB meant was that if sales don't come (or DoD contract or tender wins) in the next few months then a placing will be likely in 10 months... they have enough cash for 10 months. There will be sales though, I have no doubt :)

Divoc have posted today on Instagram about booking a PCR test. Could be ours, they confirmed a few weeks ago that they’re using it.

This is an article from last year just to show the impact that private testing labs have had, which if I understand correctly BC can sell our test to without EUA. Hopefully a good chunk of these will be interested in our high-throughput test...

"Private labs do 85 percent of U.S. COVID-19 tests but still struggle with backlogs, shortages
There are widespread shortages of test kits at private labs, and getting test results can take a week, especially in hard-hit areas like New York."

BC can still sell loads of our tests without EUA, just not on the enormous scale possible with EUA.

"There are customers who will buy without EUA, but there are a lot more who would buy with EUA. We have not quantified but it puts our focus on private testing laboratories which have more discretion in what they use compared to public health facilities and procurement requirements."

"There is a sales cycle and sales process to win accounts." ...lots will have been happening and developing behind the scenes. The next few weeks will be very exciting.

The company is not considering putting through another application, what a load of libellous nonsense.

Anticipation of positive news will drive the gap fill IMO. 115p isn’t very high considering we’ve been comfortably trading between 130-150 for weeks. On positive news it’ll be marked up way above that area. Exciting times.

Those were "aims" not predictions or deadlines, circumstances changed beyond his control. Fortunately he has managed to get a couple of incredible distribution/marketing partnerships. It's quite understandable why the Indian approval has taken longer, they have been a nightmare to deal with... constantly requiring extra information that was not asked for in any of the documentation and long waits between correspondence.

GDR have approvals already, they have also already sold Covid tests, and are almost certainly about to sell a huge amount more. FDA will likely come in the next few weeks. I think it’s reasonable to include a bit of the potential future income from Covid in their valuation :)

The rate of FDA approvals has increased over the past couple of weeks, it’s clear to see.

Seems like FDA are speeding up their approvals again, which is not surprising considering Covid wave 3 has arrived.

Thursday was a terrible day across the markets, it was unfortunate it coincided with Genedrive's interims. The interim update was pretty positive, but the effect of even the slightest negative was hugely amplified by the conditions across the markets and not reflective of the update itself. We'll see a strong recovery this week imo. On FDA approval it wouldn't surprise me to see the shareprice marked up over 100% from the current levels, and then it'll keep moving up on anticipation of big US sales, coming soon after.

End of February Thailand FDA approval came, it wasn't RNS'ed though. Well worth baring in mind that Genedrive don't seem to RNS everything... similarly there wasn't an RNS for the US FDA registration number... which is a crucial step forward in the approval process. The fact that BC Diagnostic had a test approved last week and another company (somebody mentioned the name below) very recently has been given FDA approval after 1 year of waiting, suggests very much to me a pretty high chance we will get approval within the next few weeks. Then the sales in the US will shoot up along with the shareprice.

Not to mention BC have just started marketing in Europe (last week), perfectly timed, as many target customers will be coming to the end of their existing annual contracts which will have commenced at the beginning of the COVID outbreak last year.

And then there is the hearing test being launched and POC test coming, both within the next couple of months. The price has acted as if we have had some really unexpected bad news or a huge fundraise, huge relief neither of which has happened. I can't believe we all have a chance to buy again at this price!

It's filed under Beckman Coulter (Diagnostics) because they aquired the Access product range some years ago.

That's the Beckman Coulter Diagnostics test if I'm not mistaken, not Life Sciences. But interestingly it still says "Not FDA Authorized" I'm pretty sure it has very recently been granted FDA approval.... "Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration." ...that's from a 23rd March. Us next hopefully!

Investors are upset by the ridiculous and clearly orchestrated drop, not with David. Presentation and progress with product development and product commercialisation positive and very encouraging.

Amazes me that people are going to such lengths to persuade people to sell and take a loss, just so they can buy in at a cheaper price than it already is. Crikey, 0.7 is a gift ...it will almost certainly be a lot higher in the coming weeks and months. Exciting times!

When he said “we’re not there yet” he was referring to Beckman not being able to directly influence things such as Genedrive’s FDA application. Because it’s Genedrive’s not Beckman’s.

It amused me when he had those questions from several people all asking about NDAs, he repeated a few times that he doesn’t know why they’re asking about this or what they’re thinking. He will know very well that people see the company as another takeover target for Beckman/ Danaher... but clearly he isn’t going to want to talk about it. Exciting couple of months ahead IMO.

Thailand FDA approval is very positive too.