Member Info for Doc.Daneeka

And the idea that Sakura is Org is just risible.

You're such a dullard Fruits. You make 3 kinds of posts. The first warning of impending global meltdown, the second in support of anything tangentially relevant posted by your partner in crime, and the last attacking LTHs who don't share your embarrassing old man crush on Dickie Marsden. Pathetic really - prodding away with your little stick to get a response.

I'm too busy for this nonsense but I'll make time for you if you can't keep a civil tongue in your head.

They're in the bunker - and that's where they'll stay until this is over for good or ill. But there must be a significant trial or JV announcement soon or they really will run out of money.

The basis for Td's timeline is the annual results RNS - due within the next 8 weeks. Something even the mutes at Synairgen can't swerve and which must include some kind of update. He's coming in punchy at 4 weeks because that's the kinda guy he is. Of course they might just give us a cut and paste " working at haste " update if the trials aren't ready - and run the clock all the way to the end of June....or they could tell us J&J are onboard and dosing starts tomorrow !!

If you're inviting alternative acronyms to describe the current state of play Tommy - there's as much chance we'll get a (Regrettably Not Starting ) RNS or maybe as you say there will be an ISA ( Insufficient Statistical Analysis ) event first.

MrC's chirping about updates is without doubt tiresome ( although he's taken a good break recently - thanks MrC ) but to not have made a single little reassuring chirp in 6 months really is pathetic - and of course substantially to blame for the lack of confidencewe see here every day.

I'm very hopeful Aether - just expecting traditional methods to id our cohort rather than any magic bullet from auto-abs.

The auto-ab discussion is the same as the wider big discussion about SNG. We " know it works" in a general sense - we also know auto-abs play a role - but the only question that matters in both cases is: How Much ?

Thanks Brand - another good study in the exact area of Synairgen's current interest. Shame the study didn't include Ifn B but your quote shows there a reasonable chance that the data reads across in a positive way with fewer Chinese having the auto-antibodies against Ifn-b and it therefore potentially being a useful therapeutic.

Confiming the 10% of Auto-ab for IFNs in the most severely ill Covid patients - which was found in the very large 2022 Bastard et al post-hoc study in the States, which I've posted about before.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9803887/#:~:text=Auto%2DAbs%20neutralizing%20100%2Dfold,of%20critical%20patients%20%5B8%5D.

Concerningly both studies found that the presence of Auto-abs for Ifns had no impact on mortality.

Bastard " Conclusion. In ICU patients, auto-Abs against type I IFNs were found in at least 10% of patients with critical COVID-19 pneumonia. They were not associated with day 28 mortality. "

Shanghai " Unexpectedly, we were unable to detect a significant correlation between a higher level of interferon-neutralizing antibodies (neutralizing IFN-α2 and IFN-ω at 10 ng/ml) and an increased risk of life-threatening COVID-19. We believe that the limited sample size might be the possible reason for this discrepancy, and we anticipate that enrolling a larger cohort in future investigations will help clarify this aspect. "

In the first American study they surmised that other causes of mortality - principally age and co-morbidities were such powerful indicators and determinants of outcome that the aab-ifn effective was masked and unreadable. It didn't matter. In the Shanghai study they said the low trial numbers made it impossible to tell the true effect.

My reading of all this work continues to be that assays for aab-ifns will form an important but not decisive part of the trial designs - except perhaps in ventilated patients - which almost always meet the other criteria of >80 and with existing and serious co-morbidities anyway but have the highest levels of aab-ifns. And I'm still unconvinced that UNIVERSAL will produce anything that adds hugely to the sum of human knowledge. It will show that once you're very ill you'll do badly regardless of which virus brought you to ICU.

Will it produce a test or suite of tests that will identify arriving patients beyond the 2 obvious signalsof age and illness (with a side order of Auto-abs - which kmay or may not affect outcomes ) ? I doubt it. The science still does not exist. Our P2s will be based on what the Sprinter deep dive revealed and Universal will hopefully add generic applicability of this across all the other viruses.

Remembering that they're not really trying to save lives - just to get the old croakers out of those expensive beds - and if possible to find a way to stop them going from the general respiratory ward into the land of no return.

Synairgen must be vulnerable to an extent - but as long as TFG sticks around I guess there's no reason why a deal like the 2014 AZ licensing and development partnership couldn't be struck - if the P2s are stellar and Synairgen has managed to complete them without needed financial support.

"Under the terms of the exclusive licence agreement, AstraZeneca will pay Synairgen a $7.25

million up-front fee and potential development, regulatory and commercial milestones of up

to $225 million. In addition, AstraZeneca will pay tiered royalties ranging from single-digit up

to mid-teens on commercial sales. AstraZeneca will be responsible for future development

costs.

In early 2015, AstraZeneca will commence a Phase IIa study in patients with severe asthma,

building on available clinical data from an initial Phase lla trial in a broad asthma population.

SNG001 also provides the opportunity to expand the clinical programme in other pulmonary

diseases including chronic obstructive pulmonary disease (COPD). "

https://synairgen.ams3.digitaloceanspaces.com/AstraZeneca-licence-deal-120614.pdf

Mani - thanks for the correction and apologies for the cheap shot ( altho you've kind of proved the point with another explananation of your position. The 40th or 50th I think )

Absolutely nobody believes a placing is a possibility at these levels. They could sell 25% of the company and still only just cover the garibaldis.

The 2 realistic options are that the trials start soon and they still have enough funds to complete - or that they partner with someone with deeper pockets.

Last year the date was April 17th, 2022 was May 25th, and the same in 2021.

Obviously if the results arrive without a significant update on the P2s - which is perfectly possible given the window remaining open until June 30th - then the headline will be dwindling cash reserves, which Mani will enjoy, and a continued wait for the trials to start.

The BoD will understand very well the danger of an RNS that does not contain something noteworthy and I'm sure they'll at least give us something on the progress made since September 2023. But this is Synairgen of course and they might still just give us the old "working at haste" flannel.

My previously expressed hope is that a JV is confirmed in this RNS - and our fears about cash flow are allayed. Losing a share of the company at this stage is far preferrable to the danger of running out of cash mid-trial. Shareholder and industry confidence in the company will be determined by decent information relating to the P2s and the quality of the work they've done on patient id. Obviously the addition of a BP pharma would boost confidence significantly as it would remove the financial jeopardy of a company coasting on fumes towards its last trialing chance.

We should - in any case - have something to digest within an a 10 week window - and hopefully much earlier.

Thanks Fazer - good news. Particularly after the disappointment of the new plant opening in Dublin and the govt's inability to match corporation tax and incentives. Better late than never I guess.

A dark day for the UK's life sciences sector and for pandemic preparedness. Recovery never did anything for us, and Peter Horby became a hate figure for some on this bb when SNG seemed to have been overlooked, but it did important work - principally the early discovery that Dexamethasone might save lives. Probably confirms that pointing SNG at the US was a good pivot - assuming our P2s do run there.

https://www.theguardian.com/world/2024/mar/03/uk-government-halts-cash-covid-recovery-programme

You're the one confusing Activ and Sprinter Tommy my lad. Size posts about the latter and you spend the best part of a day posting about the latter in reply.

And what the hell does your 1600 have to do with anything ? Banging on about the protocol of a trial that never happened.

Putting you in the bin until the weekend's over as you'll never stop and it's so boring.

Before I do though. Answer me one question.

Why did Sprinter fail ?

"Now Doc D would have us believe you can rock up to the regulator and tell them you’re using 900 patients and justify that by quoting some other trial for some other drug. You can’t. "

You're talking guff again Tommy - and chasing a ludicrous argument into the ground.

Synairgen DID rock up to the regulators with a 900 patient trial. The regulator was happy and even suggested a reduction as one of the arms had been removed. And then we ran an approved P3 trial with 650 patients ( circa from memory)

And if your argument is correct - that we needed 1600 then the whole exercise was futile from the start.

Are you ok ? Get some air. Leave this place for a while as you are talking utter bollo.xios

" The information I posted is from the Activ 2 protocol. It’s specific to our drug and providing sufficient power for end points of hospitalisation or death.. 1600 patients "

I still don't get the relevance Tommy. I posted about Sprinter - in reply to your challenge to Size saying it was underpowered - and you replied with irrelevant data from ACTIV2.

We knew that the P3 for ACTIV2 would involve these numbers, All the other trialists were in the high 100s or or over 1k. We'd have needed to supply just the drug and placebo. And it didn't happen anyway.

If you're saying Synairgen could never have funded a 1500 Sprinter trial then I think that's wrong too. They wasted millions running it globally when they could have run it much more efficicently in the UK, Europe and The US. Maybe 5 countries in total. Instead they whizzed off on Parexel's world tour, which caused delay and a huge waste of resouces. I said this on here long before Feb 22. They thought it would easily replicate SGO16 and be shown as a mass population >18 hospital drug - and that was a hugely regrettable misjudgement.

I won't post again on this. Enjoy the weekend everyone.

Ha what a dim-witted old duffer you are Fruits.

Paste

Cut

I've no idea whjat you're on aboout Tommy. All of the P3s of ACTIV 2 were circa 1200. Other drugs had already taken the path. SAB-185 was the drug in front of us when it was stopped dead in its tracks with more than 900 enrolled. It's what the ACTIV trial protocol required - but it has nothing to do with Sprinter.

Uter nonsense. ACTIV2 was paid for - all we had to do was provide the drug ( which we failed to do when NIH wanted to get started if you recall - amazingly ) so its size was neither here nor there.

If Sprinter had used severity of disease - the same outcome as SGO16 - as its primary outcome - and used the standard (ish) P3 trial size of circa 1000 - Sprinter would have succeeded. Who was it that said this to you Tommy ? Was it Philip Monk or Simon shaw or even the great RM himself.

Sprinter was a disaster in lots of different ways and no matter how often you tell us - oh so arogantly - to go back to school because we don't understand the science - and that it was just one of those things.... and hey Trials Fail... we ALL know it was a fu.ck up. Just imagine spending all that money - virtually all they had and not collecting samples !! I mean - the only other thing Synairgen does is to curate its biobank - but whatever - lets throw all the money on the table and forget about Dexa and Remdes and Vaxes - and not even ask them to cough into the plastic cup. Man alive !!!