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The US market has nothing to do with when a RNS lands. Synairgen is listed on the London Stock Exchange, not the US. Any respectable financial institution based in the US or wherever who trades in EU/UK equities or invest in them either have a dedicated desk working EU/UK hours to cover these markets or make use of a brokerage firm who operate those hours or who are based in the UK. Likewise if any EU/UK based firm trade in US equities - it'll be covered by desks working US hours irrespective where they're based.
Synairgen will issue the RNS at 07.00 in the morning London time - that's where their primary and only listing is.
It has nothing to do with the ticker. It's about what the company want to be called and referred to which is 'Synairgen' and not 'SNG'. All about branding and having that one consistent brand name irrespective of where you're based.
Fruits - LimaLiam has kindly offered to collate all issues on our behalf and to forward it on to Brooke.
1) Press Kit. In the Synairgen Logo guidance slide, ‘logos’ is spelled with an apostrophy ‘s’ which is wrong. An apostrophe indicates possession, not plural. (I recommend reading 'Eats, Shoots and Leaves'.)
2) Press kit. Folder containing the logo files and guides. The ‘2Col’ and ‘White’ RGB copies seem to be exactly the same. Not sure what the difference is.
3) Under the section Programmes the LOXL2 programme does not appear. Not sure whether this was deliberate or not. It used to be part of the old website.
4) Page relating to AIM rule 26. The layout is a bit weird and somewhat confusing. It doesn’t read well. For example ‘its country of incorporation and main country of operation;’ has a bullet point in front of it while the answer to this has no bullet point which is fine, but it’s positioned at the very left. This type of layout is repeated several times down the page. For some of the ‘questions’ the answer is ‘N/A’. Rather put ‘Not applicable’ as it looks like some error.
They need to redesign the layout of this page so that it’s less confusing to the reader.
5) Corporate Governance Statement page. If I expand ‘Principal 5’ for example and then scroll down so that ‘Principal 10’ is at the bottom of my screen without really leaving any space between the bottom of my screen and ‘Principal 10’s header, note ‘Principal 5’ is still expanded, then when I expand ‘Principal 10’ the page jumps right to the bottom of the website meaning I need to scroll back up to view the content of ‘Principal 10’ since expanding it.
Was going to this morning, but Liam offered which is great.
Hats off to Brooke. This, the new website, is her baby. Absolutely outstanding work. She has really thought of everything - you name it, it’s there. In general the communication/PR has been top notch since she came on board.
Only other slight ‘issue’ is that the drop down box of the ‘What are you enquiring about’ on the ‘Contact’ page does not include an option to pre-order Synairgen branded Nyetimber :-) Jokes. Need to wrap the excitement for now.
https://www.synairgen.com/investors/performance
Not showing up correctly on a mobile device. Needs to be rotated which is fine, but it’ll be better if they can either state the fact or fix it.
Thx LimaLiam. Good idea.
This is on the new website too. Brilliant video. There’s one on the website about anti vitals too.
JimSanchez - thank you, that was very helpful!
Understanding this correctly is crucial as it defines what success here means. A bit late of me to only put effort into trying to decipher this now, but better late than too late/never.
Matml74 - I assumed what the numbers could be and applied ‘trial and error’ to try and get to a z-score of 1.4. But, was failing. Haha. Yes, you’re correct the phase II data wasn’t shared unfortunately.
Correct.
But, GSK is not a well run company.
Welsh - exactly.
The mobile phone version looks good too. They just need to fix the share price information page for mobiles as it doesn't 'load properly'. If you rotate the phone it's fine.
So we have a branch in Massachusetts and the company in Delaware.
Well well well …
Type ‘Synairgen’ in the ‘Entity Name’ box, hit ‘Search’ and click on the search result for more details.
Entity name: Synairgen Inc.
Date of incorporation: 26 Oct 2021
State: Delaware
https://icis.corp.delaware.gov/ecorp/entitysearch/namesearch.aspx
Surely there must be a newly created company in the States which will employ all these new hires, unless they'll be contracted to Ashfield.
Anyone familiar as to where to search for registered companies in the States?
Indeed
US Market Access Lead
Head of Commercial Finance
Head of US Commercial Operations
Head of Alliance Management
Head of Medical Affairs
Oh wow ... a very new look to the company's website.
https://www.synairgen.com/
Joshholdforgold - many thanks for correcting me. Much appreciated. I've realised where I'd got things mixed up.
On a slightly different note I'm trying to determine the mean length of hospital stay in the treatment vs placebo group at the halfway mark which would've produced a z statistic of at least 1.4. That was the go/no go threshold to continue with the trial. But, I just cannot make it work. Not sure whether you or anyone else tried it. Time to recovery would be a bit more difficult due to it being measure over 35 days.
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4) [Effect size] The concept of ‘Effect size’ tries to determine whether the observed difference between the treatment and placebo group is large enough to be considered important. This is what Mary Aurélien’s tweet from last week referred to when he referenced 0.2, 0.5 and 0.8.
Effect size is expressed as ‘Cohen’s’ and is defined as ([mean of treatment group] – [mean of placebo group] / Standard Deviation).
0.2 = small effect, 0.5 = medium effect and 0.8 or greater is a large effect. So ideally we need to achieve 0.8 plus.
* Might try my hand at the futility analysis.
Hazard ratio
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC478551/#!po=55.7143
Power and statistical significance
https://meera.snre.umich.edu/power-analysis-statistical-significance-effect-size
https://towardsdatascience.com/the-relationship-between-significance-power-sample-size-effect-size-899fcf95a76d
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Been upping my game on the statistical definitions, hence tried my hand at explaining in simple terms what success of the trial would mean according to the protocol’s definition. Anyone who is versed at statistics please add and/or correct where I may have gotten something wrong or anyone who could be of assistance.
SG018 protocol definition of trial success:
‘Success will be determined if at least one of the primary endpoints is declared statistically significant by the primary analysis. A sample size of 610 patients in total using a 1:1 randomisation ratio (305 patients per treatment arm) has been chosen to provide at least 90% power to detect a hazard ratio of 1.45 in time to hospital discharge and a hazard ratio of 1.7 in time to recovery and at least 95% power to declare statistical significance on at least one of the primary endpoints. This sample size has been calculated using a global 2-sided alpha level of 0.05 and adjusting for the Hochberg procedure to allow for multiple comparisons. '
My observations:
1) [Power] The trial was designed to recruit 610 patients (actual recruitment # was 623) to provide power of at least 90% for each primary endpoint and 95% power to meet at least one of the primary endpoints. Meaning there’s at least a 90% probability that a statistically significant difference will be found for each primary endpoint and a 95% probability of finding a statistically significant difference in at least one of the primary endpoints. The larger the trial size the better the power.
Generally accepted practice seems to indicate power of at least 80%.
2) [Statistical significance] To achieve statistical significance a primary endpoint need to produce a p-value of 0.05 (5%) or lower which will indicate that the difference observed between the treatment and placebo group is due to the treatment received and not by chance. This would translate in a favourable difference being observed in 95% of cases/pairs. (305 * 95% = 290).
For this trial the alpha is set at 0.05 i.e. requiring a p-value of 0.05 or lower. (p-value is defined as the probability that the results were due to chance and not based on treatment).
3) [Hazard ratio] The hazard ratio (HR) is the odds of a patient being discharged earlier or recovering earlier when receiving SNG001, however it does not indicate how much earlier discharge or recovery is.
For me translating the HR into odds is easier to understand where Odds = HR/(1+HR).
Time to discharge: HR of 1.45 translates to odds of 59% (chance of being discharged earlier).
Time to recover: HR of 1.7 translates to odds of 63% (chance of recovering earlier).
In SG016 HOSPITAL time to discharge had a HR of 1.72 (odds 63%) and time to recovery by day 28 a HR of 3.86 (odds 79% ). Time to discharge was not statistically significant. [Adding phase II stats gave a bit more context around the HRs for SG018).
Thanks for the correction Doc. Somehow missed that one.
Alpha-dog
Yes, it seems omicron has indeed throw a spanner in the wheels of ACTIV-2. Only four agents (LY-CoV555, Ronapreve, SNG001 and SAB-185) out of a total of eight either made it to phase III or passed phase III. Funnily the two that passed (LY-CoV555 and Ronapreve) seem to have been bowled out by omicron bearing in mind Ronapreve is the active comparator which only leaves SNG001 and SAB-185 both in phase III.
It would be interesting to know how ACTIV-2 is going about all this, but unfortunately we've not had an update for a while. Irrespective I don't think this will make it easier for SNG001 in the sense that we'll still have to prove our worth. The question will be against what will be compared.