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https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-25March2022.aspx
The case for SNG remains strong.

Agreed. Adequately powered trial would have been much better for SNG. Ive nit lost hope of EUA though. Next 2-3 months will be interesting for SNG. I wasn’t aware of the Eiger results but literally a shot in the arm for proof of efficacy of interferon in severe viral respiratory infections. I’m guilty of being an optimist but I genuinely believe the science will come through. It’s all pointing to interferons as variant agnostic therapy. SNG will get there, just a question of when.

I am certainly not on the majority (rather contrarian view) but I’m impressed by the size of the median effect. 40% reduction in serious illness or death. Most of the other in hospital treatments don’t have anything like that effect size- their Authorisation driven by subgroup analysis from meta-analyses of trials with several thousand patients. I’m definitely a hold for that reason.

If the at home p2 data looks as good as expected that will further reinforce my view.

I’m a clinical scientist, not an investor. The p3 data further reinforces that the product works very well. I’m also an optimist and believe when EUA time comes the FDA will be true to their EUA and look at the totality of evidence. On this basis they should grant EUA with full approval pending the results of platform trial. There will definitely be a platform trial. Remember as a patient it is effect size that is important.

£2.28 minimum for me. I base this on I) Product is the best option for covid- taking median effect from p2 and p3 trials ii) variant agnostic iii) can be used out if hospital easily iv) covid is big going anywhere.
An underpowered p3 with the wrong endpoints doesn’t detract fundamentally from the products worth. I’m in for the long haul or until forced to sell by takeover.
Am I correct in saying forced sale would require TO company to acquire 90% if stock and pay highest 12 month price?

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#criteria
This makes for interesting reading on the subject. Under EUA they will consider all the evidence, including in vitro. SNG already ticks a lot of the boxes. The us lower also fir effectiveness. They will consider “may be effective”. I think SNG fits the bill. The big unanswered question at present is which patient group or groups? Inpatient or at home. Depends a bit on the activ2 p2 data and the deep dive.

My observation is that mms put in these massive spreads if they think an RNS might land at 7am. The fact that the spread is on the upside of share price suggests they may be expecting positive news. It is speculative on their part to protect against someone making a quick buck at opening price. They seem to do the reverse if expecting adverse RNS.
I’m no financial guy though and this is observation only based on a few volatile shares.

Woodie. Keep your chin up. This board has benefitted from your insights in recent past and I expect will continue to do so in the future.

Odd though. It does seem largely to track uk stock. Opening price was 0.25 usd which is pretty much uk uk closing price yesterday.

Any ideas what this means and why us SNG stock should soar today?

I think EU are really serious about energy independence and security. Green hydrogen will play a significant part. See link below. I don’t think this is fully priced n yet. A speculative increase in SP over last 3weeks but if/when confirmed we will move to the next level. Difficult to know which electrolyser companies may benefit ITM, NEL, ceres but good news imo.
https://www.bloomberg.com/news/articles/2022-03-16/germany-weighs-norway-hydrogen-pipeline-to-avoid-russian-energy

Difficulty with combined analysis is 2 different patient populations- inpatient and outpatient. Having said that I think they should combine and put in EUA. All evidence points to SNG001 being effective. The challenge is who and at what point in infection. My hope is that ACTIV2 P2 combined with the at home phase 2 will provide a statistically significant result and the SPRINTER data will support safety and efficacy of submission to recommend continuation in inpatient setting. It does feel like a long shot though…

“Prepare clinical supplies”. Sounds positive.

Ask price here is £1.40. Probably means nothing as markets closed and no rns but could it be relevant if positive rns?

Great post and great find gunto. There is a possibility they (ACTIV2) may tweak protocol to hone in on SNGs prime target group- people starting to become breathless. It does highlight the difficulties in running a trial against an ever moving target. The SNG team probably did well to get as much as they did out of SPRINTER. Hopefully regulatory authorities will understand and EUA on the basis of safety and bundled evidence of efficacy. Covid is not over.

If ACTIV2 is discontinued there is a pretty strong rationale for bundling all randomised placebo controlled data together and hopefully that will be enough for EUA. Should be circa 1000 pts. Most of the elements pointing strongly in the right direction. I may be clutching at straws.

Yes HSD. That looks like the reason. Thanks.

Am I correct in saying if there was a takeover they would have to offer the highest price over the previous 12 months.

HSD- that is correct. Some fell by the wayside. At the time of progression comparator was regeneron with proven efficacy of 70% reduction in primary endpoint of preventing hospitalisation. Regeneron has now fallen with omicron and back to v placebo so ACTIV2 ball definitely swung in our favour. Big ? medium term though is where we are with recruitment. Short term SNG should have access to p2 results and be able to share/use these.

In answer to the original question in thread. Yes. Just about to top up. The reason for this simply comes back to the science and evidence. The p3 trial in hospital was always going to be difficult. The big reason for this is that essentially the experts believe there to be two phases of covid disease. First phase up to about 10 days- fighting the virus itself. Second phase in advanced stage is fighting the pro-inflammatory cytokine storm. To support this hypothesis antivirals work early- before 5 days and anti inflammatory agents (steroids and IL-6 antagonists) work later- 10 days +. There is a big area in the middle where synairgen is the only therapy with any evidence.
Right back before confirmation of ACTIV2 p3 progression and after at home results the SNG team highlighted this as the period of opportunity for SNG- ie when patients start to become breathless (this is about day 7). The ACTIV 2 team tweaked protocol to allow this type of assessment. That discussion was the reason for delay between p2 ACTIV results (as leaked by the good Dr from Kansas) and confirmation of progression.
The magnitude of trend in benefit in hospital patients was greater than that seen for any in hospital therapy. Trial was underpowered and wrong endpoint. In hospital trials need 2000 pts.
In summary- topping up because I &still believe in the product. Next news is likely to be positive so potentially a big bounce.

If I’m any doubt about the immediate future of renewable energy, energy security and by inference hydrogen listen to Chancellor Schulz emergency speech to the German Parliament this morning. ITM should be well positioned to benefit from this alignment of geopolitical, energy security and environmental issues. I expect last weeks speculative rises are just the beginning. Germany is weaning itself from Russian gas and the rest of Europe will follow.