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Manifesto, I suggest you read the material Synairgen RNS over the course of the year and process it. With all due respect it might be better time spent than constantly bickering with long term holders ;-)

Re. Your comment on the 'science'. I'm really surprised you haven't grasped the need to accurately deliver the drug to those who'll benefit and show efficacy in a trial. Fairly fundamental IMHO.

Manifesto, I strongly disagree. I think having the tool kit to accurately target the patients that really need SNG001 is super critical as I alluded to below, prior to reading Tommy's latest post.

Fair post Tommy, although I think the changes in SOC should have been better monitored and implications understood / acted upon at the mid point. Any way spilt milk under the bridge....

Put simply this is the way I see it now. My faith to a degree is retained because the ad hoc analysis showed 70% efficacy in reduction in progression to severe illness / death in those with compromised respiratory function (1/3 of the sprinter trial). In layman's terms it seems to me there was no way of telling in advance which patients would recover from the improved SOC and those who would deteriorate further, but benefit from SNG001. Hence, big pharma haven't been interested, although the drug seems highly efficious if actually needed.

We therefore wait on improved diagnostics / techology / analysis so the drug can be given more accurately to those that need it across a range of respiratory viruses, not just covid.

Looking forward to the p2s getting underway and a new year update from RM.

GLA

Doc.D, sadly I think you are right. The only way I can see this being salvaged with no dilution to shareholders is if the P2 results are really good and we received STRIVE backing or the like. We'd have no control, but a shot at SPRINTER redemption. Otherwise we're going to have our pants pulled down at the negotiating table by the big boys. TFG could fund a phase 3 themselves (dilution for other shareholders depending on structure), but I doubt they'd trust the Synairgen team to run another one....

Doc83, your description is clearly how the market was pricing the opportunity and it may well have panned out like that on the back of a successful Sprinter result. I think success should have been much more than a 10x EM return and failure not a 90% drop in the sp. If you're right though it would suggest the company is currently grossly undervalued! Just my thoughts.

GLA

What's astonishing, in hindsight, is that the price was ever 190 gbx given the binary risk on Sprinter.

Good summary (11.22 am) that Doc.D.

Wigster77 and Doc83, thanks for posting your AGM notes. Much appreciated.

Synairgen's strategy with new p2 trial is okay, but there has to be a big question mark over phase III funding (if we get there). Some form of dilution in the form of a JV or raise (albeit hard to see at 7.5 gbx) seems inevitable, unless govt. funding can be found.

It will be interesting to see who the next agent on STRIVE is (if there is one). I haven't given up all hope of Sprinter being salvaged by a platform trial, although starting to feel a long shot. Sadly, it will probably need a new variant like ba.2.86 to cause havoc.

GLA

I think asking Synairgen at the AGM if they have any intention to relist in the states should put this debate to bed. I don't buy into any of the conspiracy theories with TGF and I think the lack of communication last year / earlier this year from RM was down to the fact there wasn't much to disclose. The team were trying to get on PT's while putting the bones of a plan B together. Now they have one.

Re. Funding. I still fancy us getting on a STRIVE funded covid inpatient trial. However, I wonder if STRIVE could eventually be a funding source for the broad spectrum anti-viral trials targeting high risk groups as announced in April. Perhaps another question to ask at the AGM.

GLA

Fair Dunk, fair. I don't see why we won't get a go on STRIVE. We fit the bill very nicely and the other two agents announced todate were ahead of us in the pecking order. We could well be next given Activ 2 results / relationship with the NIH, and given Sprinter results for those that actually needed SNG001. Two thirds of that trial didn't.

The management's communication has been sub par and will get an earful at the AGM. However, a clear plan is in place. GLA and heads up.

Ghia, with reference to your comment on Synairgen's forward looking statement. How do you think this scenario will play out if SNG001 is simultaneously in a phase 4 STRIVE trial? Given the Activ 2 results and the analysis from SPRINTER I would have thought it is highly probable the NIH will back SNG001 at some point as they work their way through the potential candidates. Any thoughts?

Wigster, the new one from the management team is working at 'pace'! Lol

In all fairness the new plan seems reasonable. Undertake a series of self funded, bespoke studies to inform a wider set of phase 3 trials while waiting to see if we get on a ph4 covid platform trial state side. Unless any investor would be happy with huge dilution from a JV (with BP) it seems the best way forward for shareholders.

I just think this plan is a good half year (or more) behind the curve, or at least the announcement of the plan. Communication certainly needs to be better going forwards! GLA

On the different route professional. I just wonder if they had an NIH funded trial as the main option and its just taken too long to initiate with no guarantee to simply sit around. If that's the case then the more recent company updates make sense, but the lack of reference to any platform trial and covid specifically is odd.

Re. The science / data from Sprinter. Not if you read the peer reviewed journal. However, I do believe it was telling that it was published in the European Respiratory Journal and not the Lancet like the phase II write up.

If money is and has always been available for the right plan then why did it not emerge post ATS when the plan appeared to be a final (platform) trial to gain authorisation? Given the covid data we have for those hospitalised with serious breathing difficulties (70% efficacy with statistical significance) then surely this is still the quickest route to commercialisation?! When you see abatacept's estimated trial competition date of 1/10/2023 (1,500 participants) then it suggests the ability to run a trial is still there. I'm slightly perplexed by Synairgen's management right now and I'm very surprised Polygon haven't forced them down this route.
GLA

I suspect when RM thought we'd be dosing patients in the winter (just gone) he envisaged it would be on a USA based platform trial. Once the team realised progress on that front was slow they started working on plan B (as formally announced today and with routes which can be seen dating back to last summer / early Autumn).

I still don't see why we won't be on STRIVE for covid given the strength of the deepdive analysis and I intend to probe this issue at the AGM. Given the strength of that data I will also be question why they didn't go for an EUA. After all if you don't ask, you don't get!

What is odd about todays announcement though is that there was no reference to platform trials at all. If we have been rejected by STRIVE then in my opinion heads should roll as accountability for SPRINTER is required. GLA

Fair summary that Doc.D.

I'm just hoping we're number 3 on the STRIVE list, but no guarantees. In hindsight we should have raised cash for a focused ph4 trial to get authorisation for covid last summer.

Thanks Gunto. Does that mean a phase II b trial can be granted authorised without a phase III? Seems odd if the case.

Can anyone comment on what a Phase 3 'registrational' programme is say opposed to a phase 3 programme?

Does anyone have an opinion on whether a "investigator-led/Synairgen-sponsored studies" means a platform trial or a JV with big pharma?

I dont know quite how it would work with being given the nod. I would have thought we would be told we are under consideration with other drugs and then at committee the NIH would choose a candidate. I'm not sure how we could be told we're on (given the nod), but then be in a situation where we had to wait until a decision is rubber stamped which could be weeks / months. In my mind we would be told we on, it's official or we're simply under consideration.

If the above is close to how it works then I'd want to know we have applied and its pending as a minimum tomorrow.

The risk is they give the company away when they should sit tight, commercialise via covid with STRIVE. Then self fund the multi virus trials. In my mind that's the only way the can save the sprinter fund raise. If they give up a huge chunk of the company with STRIVE still pending then I think the ceo would need to be sacked. If they have been outright rejected for STRIVE already then a JV with J&J (for example) is a different matter.
GLA