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Tommy, is 9 months how quickly STRIVE could be turned around? That's quicker than I anticipated. I was think 12 to 18 months for a platform trial, possibly longer.

Tommy, it's all about risk management and I'm surprised in hindsight they didn't think to do that. It's a real shame and highly frustrating. The trial is forever tainted with failure when it shouldn't have been the case following the deepdive. Given the size of the fund raise the trial should have been designed to minimise failure.

Kevin, good post if not a little down beat. Lol.

This is just a musing, but it is a shame the Synairgen team weren't a bit cuter with the end point design by breaking down patient categories, thus eliminating the need for a deep dive. If they'd have done that then we wouldn't have failed all our end points as we'd have had statistical significance and efficacy of 70% for a large chuck of the trial. I'd have thought the trial would have had to have been bigger though....

We'd have likely had an EUA by now assuming trial was a bit bigger. My concern with SNG001 for covid and passing a phase 3 trial for all going forwards is the continued risk of new variants increasingly getting weaker and SoC continuing to improve. That said, hopefully a platform trial will be more focused on those that actually need SNG001...... aka sprinter deepdive and possibly outpatients if rebranded Activ 2 ever kicks off.

Out of interest if platform trials don't materialise how much would it cost to run another inpatient trial to confirm the sprinter deep dive analysis of 70%? I could probably accept an element of dilution, albeit I might be more comfortable going down this route in a JV deal with a bigger pharmaceutical company. Be interesting to hear thoughts on this.

Thanks for sharing Tommy.

Does anyone know how the SoC will have improved / changed since the Sprinter trial was conducted and how might this impact future platform trials etc. Should we be concerned about moving goal posts again, or will this be better controlled for?

Re. The AGM. Other than steroid use contributing to the improved SoC, it is my understanding it wasn't discussed as having had a detrimental effect on SNG001's benefit. However, was this actually confirmed or is this still being reviewed. The results of the deepdive would suggest it wasn't in the cohort of patients that needed a fire putting out at c.a. 70% efficacy, but it doesn't seem clear to me.

I would think it will be discussed in the peer reviewed jounal paper when published (guessing The Lancet again).

Thanks for sharing

Doc83 and Wigster77, just a quick thank you for posting your summary of the AGM Q&A. Very useful and provides further confirmation this investment has legs, albeit patience is required.
Much appreciated.
GLA

I'd agree with all of that Tommy.

For me there are some other question marks, namely: Swapping the primary / secondary end points around, futility test passing (?!) and reducing the trial from c.a. 900 / 1,000 to 600 on the recommendation of the FDA which was a judgement call made at the time. I also think the communication could have been much better post Sprinter read out. RM left us hanging. For me none of these issues warrant removal from their jobs though.

From the limited information we have received, I also believe Parexel's running of the trial could have been better etc. It sounds like there were too many patients with covid at points.

Tattyhead61, key AGM question. Nothing has been disclosed about the futility test to date.

Aether, there's going it alone and raising new funds then there is going it alone with the US govt. funding one, possibly two trials. I'm talking about the latter.

If this goes into phase III hospital and / or home setting trial funded / managed by the US I believe this will end up being authorised.

I'd prefer the NIH to run new platform trial than big pharma in a JV. Both have risks of course. Sure big pharma spend billions on lobbying but they're lobbyng the organisation that might be running our trial. Bit of a head start.

IMO, I don't think there is any greater political capital than being back by the US govt. on something they want to succeed.

Doc83, I think what Brand means is if the market cap ever reaches 500m then it means authorisation is looking likely. If this ever gets authorisation it has such a broad application at home / hospital setting then the annual earnings could exceed a 1bn p.a., especially when pandemic preparedness stockpiling / copd is thrown into the mix. Stick 10x pe multiple on those earnings and you get a 10bn market cap. We might need to wait another two years for authorisation but I believe it has a reasonably high chance even if Synairgen continue to go it alone.

Ha, good to hear

I've noticed those trades in periods where its transpired Poly were buying. Maybe MMs driving the price down. Of course i could be completely wrong and it's just a coincidence

If that's right Sharedealer (and I also notice the 1 or 4 share share trades which i think you allude to) and Polygon are in a hurry to up their ownership stake quickly, then perhaps there is material news on its way. Let's hope so.
GLA

Pretty much Seaboy. In any case they won't trigger the 30% too soon otherwise they'd have to pay highest price paid over the past 12 months (why do that now). Plus you'd think they'd only make an offer or facilitate an offer from a big pharmaceutical company (or private equity) with much firmer evidence SNG001 will be commercialised. The sort of evidence which would raise the share price significantly. It appears a real balancing act unless a big pharma really wants to take a bit of a flyer.

Increasing their stake (for actually not much) post sprinter has just kept their options open and protected their investment as you state.

It is quite plausible (and highly likely IMO) they'll see this through until the future cashflows are more predictable (post further trials) to maximise valuation on exit.

It will be interesting to see if they start becoming more antagonistic towards the BoD if prospects don't translate into key actions (i.e. platform trials, JVs). This could start at the AGM but I think the BoD have more time.
GlA

I agree Doc. Polygon have probably made some commercial suggestions and have ongoing dialogue. However, they don't have a seat on the board. They might try to instigate a take over at some point, but still early days for that IMO..

My view is we'll be lucky if we hear news prior to the AGM. I believe they chose the date as the last possible day in June to give the greatest opportunity to hear on Activ or allow other ongoing discussions to materialise. However, the fact they shifted expectations on Activ data landing to 'summer' and funding is still being held up doesn't give me too much confidence of significant news landing short term. Hope to be proved wrong. I'm still very positive on this long term though. GLA

I agree Tommy, I think you're right - as much as we'd all like it to be different.

The only way I can see an EUA, and I hadn't thought of this until it was raised by Alpha Dog Friday evening , is if the NIH asked Synairgen to submit one as Activ 2 phase III starts with the expectation the phase III trial will fill in the 'gaps'.

However, despite the known funding issues if the data was good enough to support such an approach (you'd think it would have to be outstanding) surely this would have already happened by now!?

I therefore feel very cautious about it being a realistic option. However, I hope Alpha dog is right.
GLA

Agreed, I think if there had been a chance of an EUA application RM would have mentioned it in his proactive investor interview, or in an RNS. As you rightly mentioned I think most had given up on that possibility. Real shame as many more lives likely to be lost.

I don't share the same view that they've given up entirely on Covid, but are merely trying to sell its wider application.

HSD, re. "It's so far away it might not even exist".

I think alot will depend on how the market reacts to 1). Activ 2 data 2). getting on a platform trial (and maybe it even starting) and the new base sp which is created IF (IF, IF :-) those two events actually happen!! I'm hopeful but its not 100% given. Even a £1 + share price will feel a very long way off if those two events don't reset the sp much higher and we continue to linger sub 40 to 50 gbx.

I thought the sp might settle higher on the dd data presented at the ATS so I'm not particularly hopeful of a big change in sentiment. But sentiment can change quickly. Just look at the world in the last 6 months.....

Exactly HSD. Pretty much what I meant by this comment yesterday:

"However, on risk... this investment is in a drug research company so even strong scientific evidence might not translate to commercialisation".

No commercialisation equates to a busted flush and crystallised losses as the company either goes into administration or is sold for a derisory sum compared to the £1.70 raise / many investors average.

That said, I'm still very excited about the long term prospects of my investment here.
GLA x

Ultimately the Chairman, CEO and wider board.

Real question here though is this outright failure or just a major set back which can be overcome. Jury out, only time will tell....

We'll know what Polygon are thinking if they try and remove RM at the AGM, lol.

HSD,

I don't disagree with the points you raise, but they also went far and wide to make sure it finished. RM stated as much in interview. He also stated the biggest risk to the trial was not finishing.