Member Info for B2HS2L

govck - From RNS:
"Due to the need to modify the study design in light of the emergence of the Omicron variant of SARS-CoV-2, the US National Institutes of Health (NIH) ACTIV-2 trial team has asked Synairgen to temporarily pause activities to prepare clinical supplies for ACTIV-2 Phase 3 until the timeline for the activation of this agent in the trial is clarified."

I don't believe ' the timeline for the activation of this agent in the trial is clarified' is the true reason for the pause.
IMO they want to look at the sprinter results and the companies deep data dive analysis to understand if there is 'anything' that they can learn from this data.

Confident they will still be interested in progressing ACTIV-2 afterwards though.

With reference to RNS dated 02.06.2016

I often wondered about whether there was sufficient space in present Southampton facilities for all the new staff that have arrived in the last 18 months.

This RNS throws more light on Novacyt's Southampton facilities:

https://www.life-sciences-europe.com/news/novacyt-acquires-primerdesign-ltd-euronext-growh-alnov-aim-2001-108147.html

Larger facilities might be next on DA's list of must haves..

From 25.02.2022 RNS

"· Group gross margin before exceptional items is expected to be in the region of 70%
· FY2021 EBITDA before exceptional items is expected to be above £36.0m (FY2020: £176.1m), i.e. a margin greater than 37%, in line with management guidance of approximately 40%"

For me, they are selling tests only at the margin they desire, they don't appear to be chasing any old prospect, - eventually selling after price haggling.

This RNS makes me feel like a boxer after being knocked down for the second time in round two. (21st Feb RNS & yesterdays NIH SAB discontinuation report).
The bell has gone - end of round two - and my corner tell me there's a weakness in my opponents game play, applying smelling salts, not throwing in the towel.
There are many more rounds and I've got to stay on my feet when I'm so groggy, but I'M STILL IN THERE!

Another year at least!

https://www.labraum.at/assets/Uploads/Kataloge/95592488c2/LAB21-HC-CATALOGUE-v4-HI-RES.pdf
This is a fairly recent (25/06/2020) Lab21 document mentioning the Biotec and Plasmatec brands, and some of the products sold.

Saintsmith, Kaeren
I wrote to Mandy about what appears on LinkedIn this morning:

Morning Mandy,

With reference to the Account Manager position being advertised on Linkedin.

When prospective applicants view "About the company" they see information that is out of date (*):

Biotechnology 51-200 employees 156 on LinkedIn
Novacyt is an innovative high growth diagnostic group of companies founded in 2005 and focused on the design, manufacture and supply of a growing portfolio of oncology and infectious disease diagnostic products.
Our Brands include:
Primerdesign real-time molecular kits and reagents.
Molecular genesig - molecular testing made simple.
* NovaPrep liquid based cytology for gynecology and non-gynecology cancer management.
Microgen Bioproducts a provider of microbiological diagnostic products to the clinical and food industry.
* Biotec and Plasmatec a leading supplier of infectious disease tests primarily focused in developing markets.
Lab 21 Clinical laboratory specialist molecular personalised medicine services supporting Healthcare providers, Biotec and Pharamceutical manufacturers.

Hoping you can arrange to fix this soon

Here's her response:

Thank you for highlighting the below, I will get it looked at ASAP.

Having read the Forbes document, I don't think there will be any problem obtaining a meaningful sp move, should any future variant be more severe, because future variants will be more transmissible.
That was a good find mgmidget.

Larry10 -
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Is this what you had in mind Larry?

From RNS 29.06.2021:

Novacyt's two new PathFlow® COVID-19 antigen tests are small, instrument-free and contain all the components required for safe sample collection, preparation, testing, interpretation of results, and disposal for convenient use by healthcare professionals or patients in home settings. The use of point-of-care testing is a first line rapid screening option and, therefore, Novacyt's PathFlow® antigen LFTs complement the Company's existing polymerase chain reaction (PCR) portfolio for SARS-CoV-2 diagnosis.

PathFlow® COVID-19 Rapid Antigen Pro is a CE Marked LFT for professional use detecting SARS-CoV-2 antigens using either anterior nasal samples or nasopharyngeal samples to provide results in approximately 15 minutes. When using nasal swab specimens, the test demonstrated a sensitivity of 93.5% and specificity of 99.3% and when using nasopharyngeal swab specimens, it demonstrated sensitivity of 93.4% and specificity of 99.4%.
Both sampling methods were tested against 316 samples. This product is available immediately.
Also: Source = https://testandyou.org/e-book.pdf page 4 - The COVID-19 Rapid Antigen Pro is a professional use-only test designed for ease of use and speed for professional results.
The test is optimised for the rapid detection of the presence of SARS-CoV-2, providing results within 15 minutes.
The assay is compatible with commonly used nasal and nasopharyngeal swab types and has an in-built procedural control.
Also Flyer here 23.08.2021 - https://twitter.com/Blad3sharp/status/1429758863100760064

PathFlow® COVID-19 Rapid Antigen is a self-test LFT to detect SARS-CoV-2 antigens using oral fluid samples and provides results in approximately 15 minutes.
This test demonstrated a sensitivity of 90.1% and specificity of 99.3% from 303 clinical samples.
The test offers mass screening for home, travel, events, and workplace markets. Novacyt expects to make this LFT available as a CE Marked product shortly..

Update:
RNS 30.09.2021 - Further to the announcement on 29 June 2021, the Company's confirms there is a delay in the launch of PathFlow® COVID-19 Rapid Antigen, a self-LFT to detect SARS-CoV-2 antigens, previously expected in Q3 2021.
This delay is due to increased demand for self-test approvals causing a backlog of tests currently under review by the Company's Notified Body.
The Notified Body has communicated a delay of up to six months, therefore, the Company is also evaluating other approved options for a COVID-19 self-LFT.

PathFlow® COVID-19 Rapid Antigen Pro and PathFlow® COVID-19 Rapid Antigen have been developed with a partner through an OEM agreement in conjunction with Novacyt.

+++
1 "the Company's Notified Body" -
https://www.genesig.com/assets/files/path_covid_19_3_gene_ce_sted_ifu_issue_2_00.pdf page 2 beside REP box.

2 'Partner' - wouldn't be LFT manufacturer Biosynex per chance?

larry10 -

This might also have a bearing on Novacyt prioritising CE markings for ruo products.
Better to get CE-IVD for those products not CE-IVD labelled under present, less stringent requirements before 25th May.

From RNS 22nd Jun 2021

Novacyt's CE Mark in vitro diagnostic medical devices (IVDs) are regulated by the 1998 IVD Directive 98/79 EC. To receive CE Mark approval, an IVD must meet the "Essential requirements" of the Directive which, for some products, can be self-certified. A new IVD Directive, IVD-R, comes into force across the UK and Europe on 25 May 2022. IVD-R is a more stringent set of requirements including more detailed verification and validation data and, in most cases, clinical studies to demonstrate conformity with the enhanced Essential requirements reviewed by a notified body to approve the CE Mark. To prepare for the implementation of the new Directive, Novacyt is investing in its regulatory and clinical trial expertise to build on its existing resources, which the Directors believe provides the Company with certain competitive advantages compared to many of its competitors to be ready for this change.

Ventura -
"Many Germans never supported Hitler. But when you live in fear of what defiance brings you have no choice but to follow or suffer the consequences" -

As beautifully related in a film called 'The Book Thief' starring Geoffrey Rush.

Manifesto -
"All we know for sure is that POLY are still investing in SNG".

Firstly, - I'm not throwing anything at RM.

I've tried to map a sequence of events that allow a company known to Polygon to be very interested in acquiring SNG, and has agreed to purchase Polygon's shares when a certain holding has been acquired.
Like everyone else, I'm just trying to see where Polygon are going with their share purchases, and AFAIK this scenario has not come up on this board.

HellSD -
https://www.legislation.gov.uk/ukpga/2006/46/section/303

Companies Act 2006 Section303 - Calling Meetings.

Unaware if this has been mentioned on this board, but this regulation exists to enable any shareholder with >5%,
to require directors to call a general meeting, agenda to be announced within the meeting announcement.

ie. This has been used to replace CEO's in the past.

Thought I'd bring this to the attention of posters, because requiring SNG directors to call a general meeting might be Polygon's next move, to try to install the man who's company will be acquiring Polygons stake, and adding to get above 30%.

Trump's thoughts on Russian invasion.
https://www.youtube.com/watch?v=o53xq3CkzIA 1:00

Hi Wilson,
Can we book you for that £10 party we often promise ourselves.
If so, consider yourself booked for the £20 and £30 parties as well!

See line 2

How come the Tr1 has been released before lunch and not at 4pm today if Polygon are still buying?
That's 4 .5 hrs of time to collect cheap shares, which may have included some of mine..

Thanks ak_gabba
BIOSYNEX COVID-19 Ag BSS IFU here:

https://www.aidian.eu/uploads/COM-Documents-and-materials/ES-Products/Biosynex/IFU_SW40006_EN_V08202102R01.pdf

For professional in vitro diagnostic use only.

Manufactured by
BIOSYNEX SWISS SA
Rue de Romont 29-31
CH-1700 FRIBOURG - Suisse

We badly need somebody else to reach 3% for shareholders to have site of fresh interest.
Then we can see who gets the cold shoulder, - and it might be both.

Lewis,
Perhaps David has developed strategy - to be announced soon, - that assumed Bio would be part of the scene by then.

It seems likely Bio started buying soon after the LTIP RNS was issued.