Member Info for cider2go

What a plank!

i suspect that the EU registration and UK registration was expected to be done more or less together. thus making an equal market and kicking of the bidding from the already lined up customers. The f**K up by Mologics third party has throw the plan a little. Just my opinion.

Why is EU competent body taking so long? This is a tick box exercise, they do not review or validate any data.

"...14.What is a national competent authority and what is their role
for COVID-19 tests?
A competent authority is a government body in a given country entrusted with the implementation
and enforcement of the law in a particular sector, for example in the field of in vitro diagnostic medical
devices. It may be a government department or an agency legally entrusted by the government to
perform this function. The contact details of national competent authorities for medical devices may
be found on the European Commission’s webpage. The European Commission facilitates cooperation
and coordination among the competent authorities of the Member States.
According to Directive 98/79/EC, Member State competent authorities do not assess files of individual
devices before they are placed on the market. Manufacturers and authorised representatives (see
question 17) do need to contact the national competent authorities to notify their devices and other
basic information prior to placing them on the market........................................."

*oompa

were there any ooma loompa's?

lots of focus on the accuracy, rightly so, but the ease of use is just as much a plus here.

NOT A BRAIN TICKLER, simple and unobtrusive to use and yet STILL the best accuracy.

they need to be pushing pushing pushing the media ramp, push the accuracy compared to others , the ease of use compared to others, the fact that it is British, compared to others,
Blitz the media with this world class British development. The public should be emailing Downing street asking why the f*** are you still using this inferior kit?
.

all we need now are some oompa loompas to ramp up the production

What we need now is a massive press campaign shouting up AffiDx loud and proud to make it more difficult for the Gov to ignore, just in case.!

Looks like the ball is rolling then

Look at. DENTAL LABORATORY LTD,

Did they really add all these devices on the same day? Maybe it is a good spot ??

Unless date registered is the first date that the company was registered by mhra and maybe then each subsequent product is just added not dated

Given that it says registered 2019 not new

of course it is.
"...One study published by researchers at Imperial College London showed that viral DNA left on a hospital bed rail in an isolation room had spread within ten hours to 18 other surfaces, including door handles, chairs in a waiting room, children's toys and books in a play area. "

www.bbc.com/future/article/20200317-covid-19-how-long-does-the-coronavirus-last-on-surfaces

Though arguably this is not the main way it spreads.

Laugh? I nearly bought a round!

You are confusing two things. The email on twitter was not related to Avacta, however ironically it did turn out that our submission had been delayed due to some issue at the consultant side.

My guess is that the twittergate spurred Avacta/mologic to chase up with the consultant and they found that someone had left the email in the outbox and not pressed send!

Whatever! Lets just get there now.

or worse, someone forgot to book the lorries.. oops!

unfortunately, many will find themselves in the "not trusting what is said catagory".

1. in the original submission RNS, EU was not mentioned at all only MHRA
2. now EU submission drops in the mix
3. technically the RNS does not say that the EU submission was NOT delayed, it only acknowledges that the MHRA one was.

Anyway, I see this as annoying and frustrating (and I would like to get the name of the body that fooked up so that they can be spammed and made accountable by investors) but but not ultimately material to progress.

does read that way.

"The regulatory submissions to both the MHRA and to a Competent Authority in a European Union member state were sub-contracted by Mologic to an independent regulatory consulting agency. An error made by that agency, for which it was solely responsible, resulted in a delay to the MHRA submission which was finally made on 28 May..."

IF true, maybe, just maybe Mologic would not have told Avacta, hoping to resubmit and blame any "delay" on MHRA. just a thought.

Agreed...........but in the mean time... where's our LFT

(oops did I say that out loud LOL)