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According to the protocol hospital discharge can be considered at an OSCI score of 2 or below with no subsequent rebounds.
Brand - yes it’s not new i.e. been up since last Monday.
No new updates/additions to the website this week as far as I can see. I know they still have some issues to fix which will hopefully be done asap.
With reference to Matml74's point on quality assurance the protocol does state that quality assurance audits may be conducted at anytime during or following the study.
These were the questions asked to the patients on a daily basis post discharge and up to and including day 35. They seem pretty robust and patient-centred to me.
After hospital discharge, patients should be asked the following questions about their clinical status and return to the pre-COVID level of activity:
- “In the past 24 hours, did you experience any signs or symptoms of your coronavirus infection?” “Yes” or “No” answer will be required.
- “In the past 24 hours, did you feel that your usual activities (e.g. work, study, housework, family or leisure activities) have returned to the level from before your coronavirus infection and did not require additional assistance/support*?” “Yes” or “No” answer will be required.
* assistance/support is defined as additional help of other people and/or requirement for supplemental oxygen (or a higher level of supplemental oxygen), compared to the pre-COVID state.
Thanks for that Matml74. Much appreciated.
How does this relate to Synairgen? SNG001 is converted into a fine mist by the nebulizer. This manufacturing update from Catalent relates to micronisation of oral drugs. They only do fill/finish for us.
Just looked at it again and I’d say there’s potentially a misinterpretation. RM’s words in the WebMD interview were ‘So we get data early next year.’ In the most recent RNS they said ‘… expects top-line data early this year.‘. The latter is a bit more ambiguous although I’d say the language (i.e. top line data) leans towards publishing results as opposed to receiving data as was said in the WebMD interview.
It’ll probably be a much of a muchness at the end from a timing perspective, however it’s best not to say or assume RM said RESULTS early this year.
Just to note. I myself thought that there’s a possibility of results being (long) published by now which was based on the magnitude of the situation we found ourselves in due to omicron and so thought Synairgen might decide to crank up the speed and urgency of releasing results.
*Those receiving oxygen in the hospital setting and potentially those who are breathless in the outpatient setting.
I disagree with the statements made that 1) his comments are not great for SNG and 2) that it's the reason why the US is our target market.
RM made a comment, it was either in the 30 Apr 2021 presentation or in one of his interviews, where he stated the value in discovering breathlessness as a marker to identify which cohort of patients are best to treat. RM clearly understood the value in that and how it'll benefit SNG001 - JVT's comment explained it well. It's also been discussed on the board a number of times.
The cost of a medicine must be justified by the economical benefit it brings to a patient/health service. One of the members gave the specifics behind this calculation and it would actually be good if it can be shared again. If you don't have a target patient group the economical benefit generated by the medicine will be diluted which will have a direct impact on the price you can charge, especially for the more expensive medicines.
In short, we have already passed this test (as explained by JVT) in that we have identified the patient cohort to be treated with SNG001. Those receiving oxygen in the hospital setting and potentially also include those who are breathless in the outpatient setting.
I would caution against reading too much into this paper. The sensitivity of each variant against exogenous IFN treatment is different for each of the types of interferons, some more than others. It’s too simplistic to assume there’s not much difference when comparing the various types of interferons.
Based on a study done last year IFN beta and lamda were most effective against each of the variants with the delta variant being especially sensitive against IFN beta treatment. Refer to figure 2 of the below article – link provided.
It should be expected that omicron will behave differently to IFN beta treatment than other variants. It’s best not to speculate until we are presented with specific proof.
https://www.biorxiv.org/content/10.1101/2021.11.16.468777v1.full
Here’s another paper comparing the variants types of interferons against each of the variants. Much more detailed study.
Quote: ‘Nebulized IFNß showed potential as a therapeutic against COVID-19, and our data confirm IFNß is highly potent against SARS-CoV-2. We previously reported that IFNß upregulated 2.4-fold more genes than individual IFNa subtypes, suggesting that IFNß may induce more pleiotropic effects. Among the IFNa subtypes, IFNa8 showed similar anti-SARS-CoV-2 potency as IFNß.’
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986999/
Activ-2 phase III uses an active comparator and NOT a placebo.
Thanks Matml74 - good read.
Interesting conversation between Whyte and Topol on the topic of '2nd anniversary of covid-19' taking a retrospective view of how the US have fared. I was hoping they'd at least discuss therapeutics. Not much optimism though.
https://www.webmd.com/coronavirus-in-context/video/eric-topol-2-year-anniversary
TLWilliams. - your statement that Synairgen did not receive any assistance from the UK is just wrong. I suggest you review the events starting early 2020.
Prompt approval and commencement of our trials were extremely valuable inputs. If for example the phase II trial started a month later we would not have been as far progressed as we are now. We probably would’ve looked at H2 2022 for trial completion.
Let’s give credit where it’s due irrespective of whether you support the government or not. Could more have been done yes maybe, but I’m very happy that we have not invited the world of politics into our company’s potential success.
The recruitment for a head of finance in the UK was never advertised, not that I’m aware of though. Helen Gearing took up the position and started last month.
It’s been mentioned multiple times before that Polar (Asset Manager) and Polygon (Hedge fund) have very different strategies which is due to them being very different types of investments firms. So for what it’s worth here are the strategies for both as quoted from their respective sites.
Polar - Biotechnology fund
‘The Fund aims to preserve capital and achieve long-term capital appreciation …’
Polygon
‘To truly understand Polygon’s strategies, you have to consider our motivation. We believe we are in the business of maximizing investment returns, rather than building AUM.’
European Event Driven Equities Strategy: ‘The strategy is founded on a diversified, catalyst-driven portfolio …’ Catalysts would be Corporate restructuring, M&A, Dislocation and Special situations.
https://www.handbook.fca.org.uk/handbook/LR/6/14.html
LR 6.14.3 For the purposes of LR 6.14.1R and LR 6.14.2R, shares are not held in public hands if they are:
(1) held, directly or indirectly by:
(a) a director of the applicant or of any of its subsidiary undertakings; or
(b) a person connected with a director of the applicant or of any of its subsidiary undertakings; or
(c) the trustees of any employees’ share scheme or pension fund established for the benefit of any directors and employees of the applicant and its subsidiary undertakings; or
(d) any person who under any agreement has a right to nominate a person to the board of directors of the applicant; or
(e) any person or persons in the same group or persons acting in concert who have an interest in 5% or more of the shares of the relevant class;
(2) subject to a lock-up period of more than 180 calendar days.
Ronnycant - ever heard of the hospital phase III trial i.e. SG018 or otherwise known as Sprinter?
ACTIV-2 has nothing to do with the US hires. Definitely not at present.
Congrats to you BC and to you HeleB.
Peelweight - it wasn't a slap down aimed at you, so don't take it that way. I was making a general comment on the 'US market' reference. It's something brought up quite often on the board and so I felt it necessary to explain and address as it may mislead those who are genuinely not familiar with the workings of financial institutions.
Another reason why a 17.00 RNS won't work is because that would give the OTC market in the US, although negligible, advantage over the main London market which can't happen.
Of course Synairgen can release a RNS at any other time, but the 'US market' would not be the reason why.