Member Info for B2HS2L

Shaun, ignore if you know this.
1 Download this file -
https://filebin.net/obbxid0slw185sl0/00__Novacyt_Financial_Analysis_as_at_21st_October_2020.pdf?t=5t8849d7

2 press shift and F3 to get search facility.

Zimbabwe and Hungary deals are visible.
Apologies if the above is known to you.

earth7000, From todays meeting it would seem II's are now in the process of 'getting involved', - buying.
That being the case I would suggest that now is not the right time to sell.
I know you are sorely tempted, and you must follow your instinct, but for the above reason, (and many others), my shares are not for sale.

Agree Saintsmith, but not tempted to sell with what we know about fundamentals and prospects.
Waiting for prospects to crystallise or evaporate, but as NCYT habitually achieves the former, there is no point in selling now.
p/e needs to be nearer 10, then you know the market is no longer seeing this share as a flash in the pan.

Just so you've seen ALL the Primerdesign products listed:

https://covid-19.sante.gouv.fr/tests
Click on FABRICANT, an arrow appears beside, click on the Arrow
Look up Primerdesign in the alphabetical list created, 4 Primerdesign entries appear distributed by different french companies.

Press the Arrow at end of row to get further details.
"Nombre de cibles" = Number of targets. (gene targets)
1 gene and 2 gene targets listed, together with Winterplex assay.

Note R-BIOPHARM is a distributor of one product, but the spreadsheet has it down as a German major PCR test competitor.

JM2c

Are there many UK manufacturers of Interferon Beta please?

brrr - I think the trial would finish by default if the placebo patients are offered the drug.
You are trialling drug versus placebo, so the trial would end, everyone has been offered the drug, and any savings in time and money can be realised. Most of the money would be spent unfortunately by then in my view.

Agreed CW
Stopping the trial for 'benefit' would only happen IMO if they had already made the decision that the drug should be licensed without caveat, else everyone would be in Limbo.
Having looked at the reference material, I think there is a very good chance ph3 will not complete, because 3 patients died taking placebo in ph2, and if more don't make it in phase 3, they will not waste more time.

CW, - Like you I don't think there is going to be a problem with ph3.
I'd like your feedback on why it might be possible that this ph3 won't complete.
"Stopping a Phase3 trial for 'Benefit'" - this bb - 19.10.2020 - 21:40

Before you consider the risk of Phase 3 failure, can I suggest if you haven't already, then try reading the thread "Stopping a Phase3 trial for 'Benefit'" - this bb - 19.10.2020 - 21:40.
That might affect how you see risky this ph 3 trial is.

Hmmm, £10 roadkill?
£15 roadkill next.
Strong possibility it will happen on the same day..

Acuere, we started with a 10% Uk / 90% French investor split,
but have now been recently informed the breakdown is nearer 30% UK / 70% French.
I think this just confuses the matter myself, but thought it was relevant.
I am expecting a 'Blow the bl**dy doors off' event, so 10 Euros or £10 trigger point don't matter.

Ideally you would need a positive @ home study result, and a positive peer review before start of hospital Phase 3 trial.
If they are not positive that might hinder phase 3 progression. That's the point I am making.

True Oil, - you have reminded me they usually RNS this event.
But if Ph3 can start 30 days after IND application accepted, we surely must here something by then.

Last line:
The results of the 'At Home' study are imminent.
With the COPD / Hospital Covid trial / @ home study results available, will a positive peer review, and phase III trial proceeding successfully, stop the Ph3 trial for 'benefit'?

From Placing and Open Offer RNS 14.10.2020 -

"Following a positive pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients, and with manufacturing scale-up activity underway, the Company is pleased to announce the proposed Fundraising of up to £87.0 million to support the Phase III clinical development of SNG001 for COVID-19 patients."
Note the use of Placebo.
+++

source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024796/#:~:text=Ethically%2C%20clinical%20trials%20must%20sometimes,%2C%20benefit%2C%20and%20futility%20concerns.

Ethically, clinical trials must sometimes be stopped early when the results show no justification for exposing human subjects to additional potential risk by continuing the trial. The 3 ethics scenarios are based on safety, benefit, and futility concerns.

1.
Safety: The risks to human subjects unexpectedly outweigh the benefits because of unexpected severe adverse events. When the institutional review board (IRB) approves a trial, it has determined that it meets US Food and Drug Administration (FDA) criteria for IRB approval at 21 CFR 56.111. Section (a)(2) states: “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”11 This determination changes when a study unexpectedly causes serious illness or death in human subjects. The study may then be suspended by the FDA, the sponsor, and/or the IRB until the risk-benefit ratio is reevaluated. An example is drug manufacturer Bial's phase 1 clinical trial in healthy volunteers.12

2.
Benefit: The study hypothesis is unexpectedly proven early within predesignated criteria. Continuing to expose subjects in the inferior arm to additional potential risks or keeping them from benefitting from the therapies in the superior arm is hard to justify ethically. An example is the SPRINT study discussed above.

3.
Futility: The study hypothesis is unexpectedly shown to be unprovable within the constraints of the trial based on a statistical analysis of early study data, usually done at a planned interim analysis. In such cases, there is no benefit to balance against subjecting subjects to potential risks. An example is the cessation of the Verastem VX-6063 phase 2 clinical trial.
+++
Might the SNG001 phase 3 trial be stopped for Benefit reasons? - Recall that 3 patients died recently taking placebo in ph2 trials.

RM would have to be careful developing the predefined stopping rules criteria.
He has spoken to the FDA, and this might have been a discussed. We already know SNG001 is safe.

The results of the 'At Home' study are imminent.
With the COPD / Hospital Covid trial / @ home study results available, will a positive peer review, and phase 3 trial proceeding successfully, stop the t

From Placing and Open Offer RNS 14.10.2020 -

"Following a positive pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients, and with manufacturing scale-up activity underway, the Company is pleased to announce the proposed Fundraising of up to £87.0 million to support the Phase III clinical development of SNG001 for COVID-19 patients."
Note the use of Placebo.
+++

source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024796/#:~:text=Ethically%2C%20clinical%20trials%20must%20sometimes,%2C%20benefit%2C%20and%20futility%20concerns.

Ethically, clinical trials must sometimes be stopped early when the results show no justification for exposing human subjects to additional potential risk by continuing the trial. The 3 ethics scenarios are based on safety, benefit, and futility concerns.

1.
Safety: The risks to human subjects unexpectedly outweigh the benefits because of unexpected severe adverse events. When the institutional review board (IRB) approves a trial, it has determined that it meets US Food and Drug Administration (FDA) criteria for IRB approval at 21 CFR 56.111. Section (a)(2) states: “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”11 This determination changes when a study unexpectedly causes serious illness or death in human subjects. The study may then be suspended by the FDA, the sponsor, and/or the IRB until the risk-benefit ratio is reevaluated. An example is drug manufacturer Bial's phase 1 clinical trial in healthy volunteers.12

2.
Benefit: The study hypothesis is unexpectedly proven early within predesignated criteria. Continuing to expose subjects in the inferior arm to additional potential risks or keeping them from benefitting from the therapies in the superior arm is hard to justify ethically. An example is the SPRINT study discussed above.

3.
Futility: The study hypothesis is unexpectedly shown to be unprovable within the constraints of the trial based on a statistical analysis of early study data, usually done at a planned interim analysis. In such cases, there is no benefit to balance against subjecting subjects to potential risks. An example is the cessation of the Verastem VX-6063 phase 2 clinical trial.
+++
Perhaps the SNG001 phase 3 trial might be stopped for Benefit reasons. - Recall that three patients died recently taking placebo in ph2 trials.

RM would have to be careful developing the predefined stopping rules criteria.
He has spoken to the FDA, and this may have been a discussion point. We already know SNG001 is safe.

Results of the 'At Home' study are imminent.
With the COPD / Hospital Covid trial / at home study results available, could a positive peer review, and phase III trial proceeding suc

Your guess is as good as mine Phil, but Synairgen need to shmooze Govnt to get what it needs.
It's not as though they have little to offer!

One other question might be if Synairgen are so attractive to investors, why have large Pharma not been interested in a buyout?

The following provides information as to why foreign takeovers have not been forthcoming:

21.06.2020

New protections for UK businesses key to national security and fight against coronavirus

https://www.gov.uk/government/news/new-protections-for-uk-businesses-key-to-national-security-and-fight-against-coronavirus

2019: Population of Sweden = 10.23 Million Bruce.

Not happy with profit forecasting in this regard summers:

In the NUMIS report (dated 16.10.2020) Financial Summary - page 2, Company Specific data, we have Lab21 2019A = 6.8 2020E = 4.4 2021E = 5.2 2022E = 6.0 representing future estimations for Lab21 *AND* Microgen.

Microgen have launched 5 new products, and also the SARS-CoV-2 IgG EIA.

So it would appear that NUMIS are saying these new products will have little effect on this side of the business.

++++
From the 29th Sept RNS - Launch of COVID-19 antibody test

"Novacyt has sufficient manufacturing capacity to deliver more than three million antibody tests per month initially and the Company is working with its manufacturing partner to ensure this can be increased depending on demand."

NCYT has planned to provide manufacturing capacity for 3 million antibody tests, so there is a mismatch in sales expectation for Lab21 (& Microgen) here.