Member Info for RegulatorUK

I think it's also important to note that the Pfizer approval is temporary under Regulation 174 - so not a normal authorisation.

It doesn't surprise me. That's fairly standard for the roll out of new vaccines.

MHRA surveillance won't be everyone - it'll be a representative sample of the relevant cohorts.

"Could something be mentioned at the Downing Street press conference coming soon?"

The Twat in No. 10 will waffle and splarff his usual incoherent word salad. 'Lateral Flow tests' may feature somewhere in his inchoate ramblings, as they seem to be his 'flavour of the day' at the moment...

"Once again, lancets are not regarded as biohazard waste provided the needle is retractable which most are these days . Once used it retracts back up inside, one use only.
It’s a non discussion, so stop discussing it please."

Sorry - you're simply wrong.

Used lancets (whether retractable or otherwise) are classed as infectious clinical waste (irrespective of what they are used for) and as such treated as hazardous waste.

And we can discuss what we like on these boards...

"...I did raise the issue of clinical waste. I am now thinking that a problem with home use is how 'clinical waste' i.e. the test kit, is disposed of. Before I get shot down in flames because diabetics etc. have used such technology, their blood waste was not a biohazard. Overdramatic - maybe, but it may be something as simple as how to we dispose of the used tests or even transport them that is causing the delay."

You're not the only person who has raised the issue of clinical waste - and you are right, this is very different from the disposal of sharps used by diabetics (who I note have access to sharps bins).

The initial information from the government is that, wherever possible, testing sharps should be disposed of in sharps bins (including those available in pharmacies and GP surgeries). If none are available they've said put them in the bin.

However, that latter suggestion has caused a range of concerns - e.g. the inappropriate disposal of clinical waste (which is in and of itself a biohazard) and the volume of plastic and reagent chemicals going into landfill. I think if mass home testing is rolled out, the guidance will change and we'll see community sharps bins proliferate.

Or report his posts for being disruptive. The moderators can then deal with him.

"When Mologic get their test, and ODX do the TT-ed and have their visitect branded version say 4-5 weeks later, and get it CE approved, are mologic and ODX now competitors for the orders from UK or elsewhere ? Or has some agreement been made ?"

Mologic will probably concentrate of refining the test for the LMI country market, as it has done with others. It gets a royalty payment from Omega which helps fund that.

My condolences as well Tricky...

"Meanwhile companies like Abbot and Inova have gatecrashed the party and snapped up the Antigen Govt contracts from right under our noses."

Except what they've got are short term, interim contracts until domestic supply is established...

As far as I am aware, ODX do not have a production facility in India any more. They do have a sales team however.

"You need a crystal ball to know that!!!! It would also help to pick the euro millions numbers tonight!!!"

I've got those - but I'm not going to tell you....

"Regulator point is once this Contract is signed they with Voz will be producing. This announcement was two weeks ago, will be a pretty simple contract to negotiate one would have thought"

Not as straightforward as you might think, given the regulatory requirements for medical device manufacture and CE marking that will come into play...

I'd suggest it may another week or two before the final contract with Volz is signed and the production line there begins to flow - but once it does things will fly.

"Regulator - read the RNS from the prior Monday"

And?

"P2F is continuing to receive enquiries from prospective distributors and purchasers for its viricidal mask and now anticipates that future demand for its mask may outstrip the production line capacity of five million viricidal face masks per month."

The reference to 'production line' is to the production line they're waiting to be delivered. If you don't believe me that there is no production line in Nottingham, then just drop P2F an email (info@pharm2farm.org) and they'll confirm it - they're awaiting delivery.

People are getting confused by the reference to "until P2F has itself procured additional production lines" - it's talking about prospective future procurements. Again, if you drop them an email they'll confirm it.

" I think they are already making these masks prior to the new machines arriving."

With what? They have no machine(s) in Nottingham at the moment.

"Rubbish. They do fit the platform and model. Why do people get twisted like this. It would be to monetise modest levels of inventory.

AZ has monetised live stock for Christ sake.

Not interested in the opinions of phonies. Always a negative slim on everything."

Sorry - you're wrong. Syme do not get involved with companies in the state the Arcadia are in - they've made that clear on a number of occasions.

"Regulator.

https://twitter.com/Flashman_1975/status/1332259190576963584?s=09"

That's not a retail offer, is it? It's asking for pre-order at volume...

It's an interesting PIN, in that we know that some aspects of Operation Moonsplaff are being rolled back, but this piece of work is holding up at the increased level.

I'm not surprised to see this. It's stop gap ordering of antigen tests.... I believe in anticipation of domestic supply coming into to play.

I wouldn't be surprised to potentially see another three/six month order, if DHSC is unsure it will have sufficient domestic capacity in the short term.

"Regulator - are you a politician?? Answering a question with a nothing statement and then returning a question. We ve heard nothing of any note from ODX for sometime now. It’s ok saying odx are doing this and that behind the scenes so a gov order must only a matter of time. I wouldn’t trust the gov. They ll drop the RTC if it suits them."

My answer was clear. I notice that you've completely failed to answer the question I posed, so I'll repeat it for you: When will you have something positive to say about ODX?

"Easily verified, email mologic."

I don't need to - I can just pick up the phone. As I said, Mologic is a development company. It doesn't retail tests and it wouldn't retail another company's tests.

If you're claiming that they've sent you an email about retailing another company's test, then I suggest you post that email (headers and all). Otherwise, I'm calling bullsh*t.