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Following extract:
"These analyses showed stronger treatment effects with SNG001 in these high-risk patient sub-groups, with the strongest effect observed in those who had clinical signs of compromised respiratory function. In these patients, who represented approximately one-third of the SPRINTER trial population, SNG001 significantly reduced the risk of progression to severe disease and death compared to placebo by 70% in the Per Protocol population (Odds Ratio (95% Confidence Interval) 0.23 (0.06, 0.98); p=0.046)".
Now We are talking. Warrants an EUA IMO for the at risk groups and a platform trial for other categories of hospitalised patient.
The sp should re-rate significantly.
I think that's spot on Andy, especially the point about the RNS. My gut feel for a while has been that the long covid results have been negatively impacted by steroids etc. However, it sounded like they will be presenting decent data on the at risk groups. Hopefully with good efficacy and statistical significant. Even if the sample size is too small for an out right EUA it would get the ball moving again. I agree, this type needs an RNS so I too am surprised / slightly concerned it hasn't been issued yet. Still time, but surely the analysis has been completed so why not issue it to the market as soon as it was ready?! Any way good luck all.
Docdaneeka, I'd like to think you're right on that point. Synairgen unofficially knowing the Activ 2 results sounds logical and it would be remarkable if heads lines / snippets hadn't been communicated verbally to RM & co in recent months. Nevertheless, frustrating the data hasn't been released.....there must be a reason?!
I'm guessing Synairgen are working right up to the ATS conference on the Sprinter analysis, but again its hard to believe some of the at risk group headlines hadn't been shared with our friends accross the pond. Good luck all, not long to wait...
Hi Manifesto,
I don't doubt knock out long covid data would help justify the case for an EUA.
However, efficacy and statistical significance with a large enough sample on reduction in progression to severe illness / death amongst at 'risk patients' is arguably more important at this stage. The release of this type of data is distinct possibility at the ATS (they've already said at risk groups form part of the sprinter review analysis). IMO this is what can effectively salvage the Sprinter trial. You'd think efficacy at c.a. 50% + on this, given SoC / steroid issues, would raise thoughts of an EUA. I'm just not clear on the sample size. Possibly not big enough.
If excellent long covid data is released at the ATS that is a bonus IMO, but not guaranteed.
Re. What might be satisfactory for Polygon. IMO this depends on the quality of the data. It could range from getting their money back to £10+. They'll obviously extract everything they can though. Good luck all
Hi Aether,
Re. Your comment: " So, good deep dive P3 data, Activ-2 data, and long covid data are essential".
I wouldn't say the long covid data is essential to materially shift the sp or induce a T/O, but would be beneficial. A platform trial or take over could be initiated by either good DD sprinter data or Activ 2 data. Doesn't have to be combined in my opinion. Given the impact of SoC / steroids on the Sprinter trial I'll be pleasantly surprised if the long covid data is good / shown in the DD presentation later this month. Let's hope so though.
Re. You comment "Synairgen should then hand over to a larger pharmaceutical company with the experience to successfully pass a P3 trial".
Maybe, but wouldn't you prefer to wait even up to a couple of years for the results of a platform trial and the resulting approval / commercialisation which would lead to big returns for shareholders?
I would. It will be very disapointing (from a returns perspective) if we are bought out and SNG001 ends up being a blockbuster drug for a big pharmaceutical company!!
Good luck all and the enjoy the rest of the weekend
Hi Doc83, re. Point 2. "They got it horribly wrong by buying £60m worth pre 21/2, so clearly aren't wise and all knowing".
Bit if a sweeping statement there. I'd only agree if you knew they would be a forced seller within a specific period of time after the sp collapsed. As it turns out we know they havent sold at a loss and in fact have increased their holding.
Your statement assumes you've seen their underwriting, timescale for holding and business plan for an exit. You could argue accumulating shares at any price prior to that company becoming a multi billion market cap company should not be described as a 'horrible mistake'. In this case we don't know if that will or will not happen, but there is a reasonable chance.
If after all the trials have been exhausted and the investment turns out to be a flop then your statement would obviously be fair in my opinion.
Hi Woodstock, hope alls good. If that was really the case then why did Polygon continue to pile in, rather than cutting and running Bill Ackman style (aka sale of Netflix's at a huge loss)? Polygon will be astute capital allocators and will be IRR driven. I imagine this was signed off at IC as Synairgen had more than one bite of the cherry to get sng001 to market giving downside protection over the mid term.
If we apply for an EUA and it looks like we'll get it, why would investors settle for 3 quid when the value of the company would be worth much, much more with an EUA in place (which equates to sales)? The FDA would only give an EUA if the US actually want to use it. IMO, Polygon would block a t/o attempt on the cheap under that scenario.
If we get an EUA we are looking at the sorts of pre sprinter read out valuations mentioned IMO. The valuation would only be lower if the EUA was for use with smaller, higher risk groups (in the first instance). The lower valuation would be a function of lower sales.
This is all heresy though as right now we look a platform trial or two away from an EUA, unless the sprinter DD really comes up with the goods. My gut feel is we have a c.a. 10% chance at most of the data being sufficient to apply for an EUA (prior to seeing Activ 2 Ph II data). Any way good luck all! X
Andy, re your posts on paper losess / being burnt. Agreed, very tough for many. I've always viewed this company as a long term hold and the key for me, despite the excruciating disappointment of the top line Sprinter results, is that the story, the overall premise for the investment has never changed. This has enabled me to keep faith.
GLA
No doubt combining phase II and the 17% of Sprinter non steroid patients together will show positive results. Problem is its a small sample size as discussed previously in the aftermath of the topline results.
If they show these results combined with the high risk patient results from the Sprinter DD, assuming reasonable efficacy / statistical significance, then it will only strength the case for the following:
EUA application for specific at risk categories in the hospital setting
Full EUA
Further platform trial either indipendently or in JV
T/O approach
The more I think about it the more I hope the company stays indipendent and ends up delivering. They say its the hope that kills you ;-)
As a side note I thought the presentation posted today makes for a great intro, setting the scene, for the Sprinter presentation at the ATS.
GLA
Hi Trintyman, top notch post. Re "It’s frustrating for both shareholders and clinicians alike that this life saving drug is not yet being administered to patients".
It would be good if a few more clinicians publicly voiced this opinion! GLA
Hi Manifesto, I'll be pleasantly surprised if our long covid results have not been buggered by improvement in soc / steroids. My view is why wouldn't they have been impacted like the other endpoints. Please could you clarify your thinking.