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Yes Tommy, but arguably the stats on two other conditions which are more serious aren't stunning. 35% reduction in fatigue is okay and is statistically significant. Having only skim read the RNS, could this be to do with the lack of patients actually suffering from those two conditions?

Is it telling the RNS title didn't include 'positive'. All in all though this adds to the case that SNG001 should get on a PT this winter for covid. It will be interesting to see the presentation.

Thanks Docdaneeka and Gunto2022. V helpful responses. Let's hope you're both right on STRIVE, although as Tommy states there are other options. GLA

Thanks for the response Docdaneeka. The diamond analogy made me chuckle, very good.

My question would be then why wouldn't we get on a PT like STRIVE. What are the factors which could mean SNG001 is overlooked? What other drugs might be better. For a start are the deepdive analysis results (ie 70% efficacy in a sub population which represented about a third of the trial that actually needed assistance over and above SoC) actually that good? Are we looking at them through rose tinted glasses? Or is this drug really the nuts.

Ghia, I could envisage a JV trial and licencing deal for COPD being on the cards following the recent data. However, I think they'll really have had to have exhausted the PT route options for Covid (pre BP JV route) otherwise it will crystalise the capital destruction of the Sprinter fund raise by giving away too much value. Neither do I think we could do a covid BP licencing deal with Activ 2 data outstanding. Throwing it back if we don't get on a platform trial pre 31 December 22 does that mean we've exhausted the PT route. I don't know?! I'd like to think not, but it might mean we've missed a winter covid spike to assist in trialling. In addition, it would mean another quarter of down the road eating into the businesses cash reserves. In any case plenty of potential news flow to look forward to.
GLA

Billy, if SNG001 ever gets to market Synairgen will be worth many multiples of your exit / breakeven price. On balance I think this will eventually be happen, but you might have to wait 2 to 3 years at least especially if we remain independent by going down the platform trial route which will be slow (although if we get on STRIVE maybe its a little bit quicker).

Re. Realising your exit price sooner. It might only come via a take offer (or possibly a licencing deal) which might occur once we are on a platform trial and the UNIVERSAL trial results have been published, thus thereby identifying the size of SNG001's market as a broad spectrum antiviral. I'd have thought we are a year off that sadly.
If you can remain patient and park this /write this off for a while you might end up with a big reward in the end. Just my thoughts.
GLA

I agree Wigster, although I'll feel more comfortable when a trial where SNG001 is actually being tested is announced! Ideally a phase III for hospitalised covid 19 patients.
GLA

Re. Kevin's point. "we now know it only has limited success with a small sub group". Opening this up for debate.

Is 70% efficacy limited success and is a third of the trial in most need of the treatment where SoC doesn't work (oxygen levels <92% etc) a small sub group? Won't the proportion of those suffering these levels of accute respiratory symptoms be dependent on the nature of the virus. A particularly nasty variant could result in a much higher proportion of people turning up at hospital in need of SNG001 and therefore falling into this 'small sub group' as described by Kevin.

While this drug is about the here and now, pandemic preparedness is where the big market is for Synairgen. This has always been the case going back to the punchy broker notes.

*unusual situation

Sprinter failed, but only because the end points didn't sub-divide patient categories and due to the relitively small size of the trial. Those that actually needed SNG001 (one third of the trial) benefitted with a reduction of progression to severe illness and death by c.a. 70%. It would be interesting to hear their thoughts on Synairgen!

Stand to be corrected with examples, but I suspect this is an usual situation in drug research investing where we have clear evidence that a really important drug works well enough to commercialised with a big market, yet the share price doesn't reflect it due to the operational and executional risk associated with bringing it to market. Normally there are both hurdles. As such I feel the suppressed share price is overdone, even scarred by the Sprinter RNS (this will take some reversing). Nevertheless the operational risk exists (i.e. need for additional trial (s) who ever funds them), but the risk / reward profile looks attractive IMHO. This of course doesn't help those heavily underwater right now, but the info revealed at the ATS should give us great hope that this will eventually come good.
GLA

Irrespective of the hotly debated reason for the delay, clearly Synairgen didn't agree a topline data release clause. Hindsight hey

Fake news, lol

Feeling positive then Kevin lol

It's just obvious to me any way. A platform trial might test efficacy against other respiratory viruses, but that trial will be attempting to confirm findings of Synairgen's preious covid trials.

COPD / Asthma is clearly on the back-burner though. The primary objective for the company is to get SNG001 approved for Covid. We have probably 18 to 24months to achieve this. Revenue streams from Covid can then fund COPD / Asthma research.

Right now to survive as a business the primary objective which has to be realised by hook or by crook is an approval for SNG001 otherwise a fund raise will be needed to move forward / survive or a JV with big pharma will be needed. Otherwise there would come a time when someone would be buying the ip rights out of administration.

'The Premonition: A Pandemic Story'by Michael Lewis is an interesting insight into how the pandemic was managed in the US. Well worth a read.

I doubt it Tatty, there is always a base line SoC with trials. I'd be very surprised if the BoD / team weren't aware Steroids etc. would be used in the SoC. I think what caught them off guard was how beneficial / effective the SoC was at treating two thirds of the trial. Importantly, given the 70% efficacy on those with oxygen levels <92% etc. (ie need it most) it seems steroids weren't effective enough and didn't have a negative impact on SNG001 effectiveness. This is a key issue and initially it was thought steroids ruined the trial, but this appears not to be the case.

If we get another nasty covid variant the number of patients needing SNG001 might increase again from approximately 1/3 of patients admitted to hospital (excluding those going straight into ICU).

In hindsight, I think the trial end points should have categorised patients (eliminating the need for a deep dive exercise). I believe not doing this was a mistake and we would have an EUA now.

Aa far as I'm aware how the futility test was passed has never been explained. It should have been IMO.

I think its been speculated on here that the SoC for the second half of the trial improved significantly, thus reducing the pool of trial patients that needed the drug. In reality it was probably a steady improvement in SoC accross geography for the duration of the trial.

Given the obvious shock at failing the end points and apparent paralysis of RM to communicate with his shareholders in the immediate aftermath of the results, it's fair to say they thought Sprinter would be successful after the futility test.

I'm not sure how they would 'know it works' if the results suggested otherwise?

No, I suspect it was evidence based and they saw enough in the trial results to pass into into phase 3.
Any way, time will tell.
GLA

HSD, they've have already announced it has passed into phase 3 so that would suggest otherwise....

More plausible is that they've been holding the release of Activ 2 data back as the Activ programme was put on hold, possibly to be revamped and due to fundingissues. The rise of Omicron was also muted as an issue.

IMO I doubt the US would release data until they're ready to progress. All about staying at the front of the queue. Why release the data and allow Synairgen to use it to jump on a platform trial in a different country. A bit of a cynical view but it's all about interests.

A good point to highlight Tommy