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Nice £5m acquired without diluting shareholders.
YGEN opening up Canada facility today, 4x previous facility's size.
Well done to all at YGEN.
A buy went in a minute earlier at 12.25p. Would they have got them at 12.15p ?
Hi Bakky,
Yeah I would like to understand the regulations and the way they are called out. Too long spent working in a different highly regulated industry...
Can you be certain they were buys though?
Ella, I see you are asking Regulator for answers. Good idea as they will know more than us pair no doubt, lol. TBH my bleedin' heads spinning with all the regs..
Hi Bakky,
MDR 2002 has been modified so that regulation 38 calls on the requirement for CDTA. MDR 2002 regulation 39 gibmves the process for exemption and this is quoted in the protocol doc.
The mods to MDR 2002 to cover CDTA are in the link below. I therefore don't think the requirement can override the allowance for EU approved devices (but am not certain how the EU exemptions until 2023 are called out).
https://www.legislation.gov.uk/uksi/2021/910/contents/made
Ella, apparently the CTDA is in addition to MDR 2002.
I am a s/h of the company. I am entitled to know if they are approved or not to sell their only covid test !!
This is what I am trying to establish.. Why ask yourself won't the company say anything?? One sentence to confirm it..that's all I need. One customer says they are not approved, yet they are still supplying MHC into Boots..
'' Provided they are not withholding market sensitive information or selling tests illegally then I can understand why they don't want to engage in explanations here''.
and as for witholding market sensitive info, well we've been there before haven't we? Core sales are hardly impacted at all he says, yeah right!!
Ella, picking up on your last post. It might well be part of all sorts of different sub clauses but it still needs passing a desktop review and then a lab test. Why are Ygen not on the approved lists at all? Why have customers said they are not approved? Why hasn't the company just quickly replied?? This excuse about they are busy and haven't time is a joke! If their tests are ok to sell, why on earth wouldn't they say so, one short sentence will suffice.
smudge, I think mdna had other suppliers prior to Ygen as they already supplied into NPH at Newcastle airport. I think that's correct, unless anyone knows different?
Davand,
I agree it's confusing but I can see why Yourgene don't want to start explaining regulations to individual shareholders. It is likely to end up in confusion at some later date. Provided they are not withholding market sensitive information or selling tests illegally then I can understand why they don't want to engage in explanations here.
'On 31 July 2020, Elucigene Diagnostics, part of the Yourgene Health group, made a manufacturer's Declaration of Conformity that their Clarigene™ SARS CoV-2 test complies with the provisions of Directive 98/79/EC on In Vitro Diagnostic Medical Devices and that the in vitro diagnostic medical device can now be CE marked and placed on the European market'
My understanding is that the CDTA process is part of MDR 2002. Il
Is the mdna supplier the same one as quoted on the ygen website for using clarigene?
https://www.yourgene-health.com/covid-19-day-2-and-day-8-testing-service-providers
Ella, I still think no matter what, every COVID test still has to go through CTDA approval to sell in the UK. It's very confusing, so a little help from LR would do the trick
Ella, it might well do, we don't know hence the question to the company. NPH confirmed that ygen didn't have approval last Nov, and as far as I can tell they still haven't, but we need them to tell us one way or the other.
Hi Ella, tbh I don't really care too much as regards the registration, I'm more concerned at how the company treat their shareholders, I don't have to like the company to be invested. But I find it hard to stay invested in people I hold no respect for.
If they had approval then surely they would have said so from day one last Nov. That's what 's nagging me. I know they put in their application along with many others. As far as I can tell, along with many many others they are still waiting. The confirmation from NPH just confirmed it for me that from last NOV they were not approved. Yet they are still supplying MHC /others as far as we know.
If these companies have plenty of stocks and Ygen haven't sold a thing since Nov, then fine, why not say so, problem solved. OR if they had a special license or something similar then just say so.
Does this not apply
All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR
Ie there are other routes to market than MDR 2002?
I agree it annoys me that we, as shareholders should need to act like detectives trying to uncover simple facts within the company we invested, this is not some effing secret organisation for Pete's sake its there in print, For Media & Investor Relations contact: yourgene@walbrookpr.com. or for info contact: info@yourgene-health.com.
I have done so . We should not be made to feel like it is US at fault, or it is US being a pain, its a simple bloody question we should be able to get a simple answer, or indeed any answer. Like I say arrogance and full of their own self importance, damn I would love to see a proper shareholder revolt and throw the CEO out on his ear.
Frankie, we shouldn't need to ask anyone other than ygen should we? Just what is their problem with supplying an answer? Are they approved or not? Quite easy for them!
Frankie, how can we be sure if they won't say what is going on? If they are still supplying MHC then confirm you are approved by CTDA.. They won't or can't!!
'As long as Yourgene have not been unlawful in selling the Clarigene test when they shouldn’t have been, then hard hats won’t be needed'.
Stas, I think they are still selling. Who else is supplying MHC? Can't sell to NPH, but can to MHC/Boots?? hmmmm!
Just had a quick look at providers and a few still have ygen listed on the government website are these not to be believed. Or am I looking at the wrong thin
Frankie, not sure about being nervous with MHC, I am getting nervy here!