The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
Latest update a few hours ago on Activ2:
https://nihrecord.nih.gov/2021/03/05/four-potential-therapeutics-covid-enter-phase-23-testing
Confirmation that the first volunteer enrolled in the SNG001 sub-study on Feb. 10 and that the other agents under study are expected to begin enrolling participants soon. ie the others have still not started! Does that mean we have had no competition over the last 3 weeks and all volunteers would have been enrolled on our trial?
Based on the time frames below for Operation Warp Speed for Eli Lilly, I'm estimating that we should receive interim analysis the week after next. Any views?
4th Aug - First patient dosed for its monoclonal phase2 trial, approx 220 non hospitalised patients.
5th Sept - Last patient was dosed
15th Sept - Interim analysis published
If promise is shown in interim analysis, logically pre orders will follow...
All you need to know is contained within the peer reviewed journal which was published in November:
https://www.synairgen.com/wp-content/uploads/2020/11/201113-Synairgen-Lancet-Respiratory-Publication-FINAL.pdf
LL’s average must be less than 10p. He has been reducing since March/ April when the SP started to rise to circa 30p then up to 70p, through the P2 results in July. He held 7.4m shares in August and 7.8 m in July, having had 9.7m in March.
Therefore he has not been reducing on any new news, but gradually selling over the last 6 months.
I’d have been doing the same with that amount of profit to take. I would then leave a bit in for the holy grail. These II’s can only sell once and others must be taking them at a higher price. It just a ‘changing of the guard’ and a natural progression in the SP’s life of a company that sees it increase in value over a short space in time. It also explains why we are not much higher at this juncture.
https://www.nihr.ac.uk/news/covid-19-treatment-results-published-in-journal-ahead-of-nihr-supported-phase-3-trial-of-nebulised-interferon-beta/26186
Professor Nick Lemoine Medical Director of the NIHR Clinical Research Network said:
“Results from early phase research into Synairgen’s respiratory treatment, SNG001, show this drug’s potential as an effective therapeutic option for Covid-19. As an urgent public health study, the phase 3 trial will now be prioritised for fast track set-up and delivery across the NHS - on a much larger scale. This will give many more UK patients the opportunity to take part and potentially benefit from this exciting new treatment, as we move into the second wave.
“NIHR-supported research has already given the world the first proven treatments against this new disease. We are pleased to further support the incredible innovation emanating from the UK by delivering this large-scale trial of a Covid-19 drug developed by Synairgen -
https://www.thailandmedical.news/news/breaking-sars-cov-2-mutations-washington-university,-mayo-and-harvard-scientist-identify-new-48-sars-cov-2-rbd-mutations-resistant-to-antibodies
It would be wise to read this and understand that treatment that would work on any virus, no matter how much it may mutate is going to be essential.
I'm also exicited about the results of the COPD trial. I found this paper interesting:
Http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6553750/#sec014title
'These results strongly suggest that COPD patients undergo a partial suppression, most likely of epigenetic origin, in the lung IFN-ß gene expression. Moreover, this deficiency could be the cause of a negative control loop that would lead to a decrease in the production of MDA-5 and RIG-I, resulting in a poor IRF-7 activation and, ultimately, explaining the deficiency in IFN-ß expression. Our data support the hypothesis that COPD patients have an impairment in their lung innate immunity and, consequently, are more susceptible to infections and thus more vulnerable to suffer exacerbations. We believe our results open a new window for a treatment with interferon for frequently exacerbated COPD patients'.
According to the resident scientist on the other site, this sort of study is called ex vivo and Is much more informative and believable by everybody than in vitro studies.
Forest, regarding the hospital trials and your point 1:
Early treatment may lead to better results compared to later treatment, but having said that see link below:
https://www.frontiersin.org/articles/10.3389/fimmu.2020.01061/full
This trial showed that in hospitalised patients, inhaled alpha (not beta which is thought to be more efficient) interferon had beneficial effects on viral load and IL-6 levels. This is strong evidence that the hospital trial should be positive.
Not sure if the link below has been posted before but it also illustrates that the USA are now aware of the potential of SNG.
This report mentions us along with other USA companies with billion pound market caps!
'Huge growth expected in Coronavirus infection market in coming years'
https://www.biopharmapress.com/huge-growth-excepted-in-coronavirus-infection-market-in-upcoming-years-complete-analysis-by-2020-2027-profiling-top-key-players-inovio-pharmaceuticals-inc-novavax-inc-protein-potential-llc-alp/
Note that in this trial the interferon was injected. With our trial it is inhaled.
It is thought that inhaled interferon is more efficient as it goes direct to the lungs and also a safer form with fewer side effects.
Apart from the fact that these are desperate times and maybe SNG only needs to show safety and some minor success to obtain approval, note that the RNS on 30 April on the extension of the trial to the home environment means it is no longer a binary decision. This is because the home trial will be reported after the hospital study. They are separate trials ie two chances of success.
I posted this last week:
I was wondering what the definition of a successful trial was, so that I could assess the risk of my investment. I don't think this is the binary bet to the extent that some people may believe. On this subject see the link below:
https://www.fiercebiotech.com/biotech/gilead-s-covid-19-hopeful-remdesivir-may-get-swift-japanese-approval-report
'Japanese Prime Minister Shinzo Abe is set to grant Gilead Sciences' experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works'.
These are desperate times and maybe SNG only needs to show safety and some minor success to obtain approval?
Note, the drug has already been delivered to lots of people in various trials with a very good safety record, so there shouldn't be any safety issues!
Everything points to a successful trial, but based on the above, I believe the risk on an investment here is reduced.
I was wondering what the definition of a successful trial was, so that I could assess the risk of my investment. I don't think this is the binary bet to the extent that some people may believe. On this subject see the link below:
https://www.fiercebiotech.com/biotech/gilead-s-covid-19-hopeful-remdesivir-may-get-swift-japanese-approval-report
'Japanese Prime Minister Shinzo Abe is set to grant Gilead Sciences' experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works'.
These are desperate times and maybe SNG only needs to show safety and some minor success to obtain approval?
Note, the drug has already been delivered to lots of people in various trials with a very good safety record, so there shouldn't be any safety issues!
Everything points to a successful trial, but based on the above, I believe the risk on an investment here is reduced.
To those bored sellers chasing other stocks with the intention of getting back in later, the video below is reminder that there is interim potential news to be RNS'd.
https://www.youtube.com/watch?v=Hd7VlwHosZA
For example and all from the video:
1. In relation to the hospital trial RNS on 18 March they will 'give out data every so often to the Market'
2. It stated that 'very soon' they were to 'implement home based treatment' and were 'confident that this would start in the coming weeks'. New on this imminent.
3. It was stated that they were 'looking down the supply pipeline for the manufacture process'for delivery of drugs etc to make sure they are in a position to provide millions of doses around the world' . News could drop anytime in this issue also.