Member Info for Doc.Daneeka

Attended a very interesting AI lecture last week - given by one of the top US AI experts. One of his examples was taken from medical research and showed the quantum advances that AI has made possible in statistical analysis. His example concerned drug interactions and the speed and accuracy of AI analysis in profiling 10s of thousands of potential drug combinations , adding in patient medical history and age/ allergies etc. The contrast was with a technician looking at each of these possible interactions manually. The 100s of man hours compared to what AI can produce in minutes.

Most of it was way over my head but we've seen in so many ways how important Ai already is in medical research and data processing - and it would seem that it ought to play a critical role in the trials we are about to embark on.

One of the boys was asking about our AI capabilities recently - was it Jint or Wigster ? - and it's a really good question. Does the company have the expertise in-house to make full use of AI ? Presumably Janssen has plenty of expertise but we don't know quite how much it will make available to Synairgen. Could Synairgen have laid off a couple of the redundant commercialisation hires and got a couple of Ai specialists in through the door. ?

Gosh thanks Ghia - warm tingley feelings all over my body.

Thanks Johnnyboy Part of the package and something they had to notify then. Can't see anything to get exercised about really - unless they are supposed to stop functioning completely. We hope the new hires add value beyond what they cost in salaries and options. Of course it doesn't read well to us, but nothing will, until we see the sp start to climb .

Best wishes to you for a strong and full recovery :)

Is this just for the new hires ? If so it's probably automatic and part of their package. Doesn't look good to us but sop. If it includes anyone else, that would be another matter. Could someone please clarify ?

Blimey, you're back again. Worrying at it like a dog. I'm not going to respond though. Not because you've got me and I can't reply - but because tomorrow is a new week and we've gone back and forth on this enough and I'm sure the bb would like to start a new week with a clean slate. Take that as a win if you like and enjoy the rest of the weekend. You're still the best informed and most enthusiastic poster on this board and i hope you'll take THAT as a win at least and we can move on.

You keep banging away Tommy. Be my guest. Nothing I've said equates to a rant - but your constant pointless theorising and stretching of narratives over dozens of posts in the last few days adds nothing whatsoever to the debate. We'll know what the start point is in the next 4 or 5 months - unless the goalposts shift again. And I won't believe anyone in Big Pharma is really interested in the drug until we see an RNS confirming it . They certainly won't move until they see something fantastic from the P2s. Which Synairgen may or may not have the skill and technical competence to deliver.

I haven't modified my position at all Td. All of Synairgen's trials except the hospital arm of SG016 were underpowered or poorly designed. Even without the data profiling that is now increasingly becoming available, Sprinter could have succeeded quite easily. AZ blew the Asthma trail - so I guess that's not to bew laid at Synairgen's door - but they also weren't interested in revisiting it or redesigning - as they said they would originally.

They didn't even start to look at the COPD data until after Sprinter failed. This data might have helped them to design Sprinter if they'd had it sooner. I don't think the new technology was needed to measure viral clearance.

I was reminding the board that your "after 20 years - the world has finally caught up with Synairgen's vision " narrative is fanciful. And the fact that SNG is a niche drug has only recently been discovered. The Asthma trial AZ conducted with it failed because not enough patients got ill. In hindsight it's clear that it wasn't that the trialists didn't become ill enough - they just needed to be selected more carefully. Likewise with ACTIV 2 - where the inclusion criteria was deeply unfavourable (anyone over the age of 18 with covid from memory ) And even Sprinter - which needed another 100 or so patients to make statistical significance as they weren't stratified enough (anyone hospitalised with moderate Covid )

When SG016 came in so big RM was telling the world that the entire pandemic might have been averted if SNG could have been rolled out across the globe in the early stagers of the outbreak. We know that this was nonsense and that the 79% result only really worked in a Year zero scenario and couldn't be repeated for Covid when SOC in hospitals had improved.

So - and forgive the long winded and slightly half formed theorising - the reality after Sprinter is that the company realised its drug could work very well - even on top of SOC for a highly targeted subset of patients. And at that point the search for tests that would enable this population to be discovered began.

RM and PM clearly hadn't thought of any of this earlier in the pandemic, certianly not in the depth required or they wouldn't have wasted the fund raise money attempting to prove SNG as a mass market blockbuster. They've learnt a lot from the Deep dive and from the belated work on the COPD data - and now finally - with new biometrics tools hopefully in hand they will embark on the right trialing programme, but unfortunately without the funds to convert anything successful into the P3s that will need to follow.

With luck the P2s will be so well designed that the sp bounces into the 40s or 50s and the company has a strengthened hand in the dilutory process that will inevitably follow.

I get that aether but it just got really messy with accusations of paedophilia and all sorts of terrible stuff like that. Stuff that none of us knew the truth about or wanted to hear more of. Polluted the board for a long while and however messy it can sometimes get now, it's never as bad as it was then.

It really wasn't much of a tale tbh Aether and definitely not worth the re-telling. Org is still over on ADVFN though if you really want to know.

We speak a lot on here about the P2s leading to a single P3 - but that's not what we've been told by the company. The prep work - both in the 2 or 3 P2s and the other work that's ongoing should lead to multiple P3s.

RM - Interim report...

" We hope to maximise the benefits of treatment with SNG001 by targeting patients most likely to respond to treatment by applying both existing and new technologies for patient selection in our next trials of SNG001. This will enable us to focus on the most appropriate patients which will ultimately lead to trials of SNG001 in more targeted, but still large, patient populations at high risk of severe outcomes.”

Did Sprinter fail because they lacked biometric testing Tommyd, or because the trial was too small, had the wrong endpoints and failed to consider the impact of a SOC drug that was authorised and in use all over the world long before the first patient was dosed ? Asking for a friend.

30th post in 2 days from Tommyd andif you thought he was starting to run out of steam - he was ropeadoping us and saving the best till last. Easy to miss with all the Spacman fun - but it really is an all-time classic

"The answers are there if you take the time to listen. 20 yrs waiting for scientific advances, understanding and the recognition of risk from respiratory infections to catch up "

In Tommyland, it was the rest of the world that was at fault - while 1000s - no tens of 1000s of other new drugs were developed and brought to use - SNG001 was waiting......... waiting for the medical science community to realise the "risks of respiratory infection " and for the new biometric tests to arrive that would see RM knighted and bedecked with laurels.

It's comedy gold Tommy, and this on a day when Spacman has already had us rolling in the aisles ( although I thought his paragraph on the hubristic decision of RM and the board to " go it alone " in hopes of creating a new BP with their wonder drug was very well remembered and articulated - and it's something I've posted on before. It really made me chuckle, remembering all those ridiculous January 21 posts suggesting we'd be the next Biontech with an mcap in the tens of billions. )

thanks buddy - smile of the week :)

You've mentioned AZ twice today. Fruits at least a couple times recently. I've added context to the $7.5m punt - whuch might have led to "100s of millions" but in fact ended in the drug being retuirned to base after 2 years.

It's not in the trophy cabinet - let's put it that way.

"It does seem odd that Astra Z were prepared to invest significant 100’s of millions of dollars into a company that weren’t doing anything significant or interesting. "

Plenty of genuine reasons to be optimistic - but to keep dragging up the association with Astrazeneca and the potential deal worth "100s of millions", when the reality is that AZ licensed SNG001 for $7.5m in 2014 - began a trial in Asthma in July 2015. Stopped the trial in 2016 as patients weren't becoming ill enough - and promised to redesign the endpoints and try again - before cancelling the arrangement entirely a month or two later and returning the drug to Synairgen.

There may have been specific problems with trial design and endpoints that a company the size of AZ could take time to put right and go again - but they didn't take that approach. They just said no thanks and cheerio.

It's possible AZ are back on the scene and have seen more promise in the COPD and Sprinter data - but until they show their hand again, we'd do better to concentrate on the good data we have and the potential the P2s hold rather than looking back at an unfortunate misstep along the way.

You’ve stated repeatedly that you think they’ll complete the trials and have results next year. I think that until we have a start date your position is blinkeredly optimistic. But blinkered optimism is your default - so no surprise there.

Let's hope for an announcement before Christmas or early in the New Year to say that all is ready and trials are about to start.

Fruits I

Don't assume you will be told when P2's Start.

-------- Of course we will be told. Every other trial has been announced in advance or at the point of first patient dosed.

Don't assume trials will only be in the UK.

-----------------No evidence to suggest they will take place elsewhere - but happy for you to share any knowledge

Don't assume the clinical trial window for RSV stops dead in March - for US based trialling the NIH note that "Nationally, prepandemic seasons (2017–2020) began in October, peaked in December, and ended in April. During 2020–21, the typical winter RSV epidemic did not occur. The 2021–22 season began in May, peaked in July, and ended in January. The 2022–23 season started (June) and peaked (November) later than the 2021–22 season, but earlier than prepandemic seasons. In both prepandemic and pandemic periods, epidemics began earlier in Florida and the Southeast and later in regions further north and west. With several RSV prevention products in development,† ongoing monitoring of RSV circulation can guide the timing of RSV immunoprophylaxis and of clinical trials and postlicensure effectiveness studies. Although the timing of the 2022–23 season suggests that seasonal patterns are returning toward those observed in prepandemic years, clinicians should be aware that off-season RSV circulation might continue."

------------------------------ A reasonable point - although your use of US pandemic stats is rather unhelpful - as you quote yourself "the timing of the 2022–23 season suggests that seasonal patterns are returning toward those observed in pre-pandemic years "

FYI. RSV in the UK. The season usually starts in October and last 4-5 months - peaking in December - so for RSV it’s possible that even if they miss the tail of the 23/24 winter - it’s possible there will be good data harvested in the later months of 2024.

Don't assume a small targeted P2 will take a year or more to complete. Latest technology being used by the company could hasten things considerably for a highly stratified cohort. I expect months, not longer. And how much more data would an interested BP need to initiate a deal? The tipping point may be lower than you expect.

--------------- again no assumptions made. I asked do they have the tests ready - if you have any evidence to show that they do - or that they plan to use off the peg Casanova labs despite them saying they don't - please share.

Don't assume regulatory discussions are not already well advanced. ----------

Who assumed this - again I asked the question. "How far along are they with regulatory approval. "

They ought to be well advanced but we do not know if they are or not.

Don't assume diagnostics required aren't already clinically available (even if not commercially...)

--------- My question was "Do they have the diagnostic/biometric tools ready ? " That's again a question - not an assumption

"my expectations for the next news is hearing more about these trials (be-it protocols/commencement dates etc) some time around February/March."

I hope that's not the case Wigster. If we don't have protocols and if the trials aren't well underway before Feb/March 2024 there's zero chance of them completing next year. It's touch and go anyway but the original intention was to use this winter flu/resp disease season, and by March it'll be almost over. We have to hope that H1 means January and that we'll hear more in advance of this.

Remember also that despite the small numbers - maybe 25-40 per trial - this is such a select cohort that almost everyone who wheezes their way into hospital will not qualify. Which might not be a problem if the trial runs at lots of hospitals - but it almost certainly won't, so they will probably still need months to get to LPD.

Still so many unknowns which - unless we get a positive announcement in the next 4 or 5 weeks - could easily send these trials into 2025.

1. Do they have the diagnostic/biometric tools ready ? ( we inderstand it's not going to be off the peg )

2. Are they still waiting for further evaluation of UNIVERSAL before designing the protocols (what we've had so far is not specific enough )

3. How far along are they with regulatory approval. ( Multiple approvals required )

4. How many sites.

I thought Ghia a while back. Mostly because of the professed "inside track" and also the genuine depth of knowledge about the company. Sure Ghia would have been more tetchy in the face of all the abuse though, whereas this chap lets it all flow over him.

It's the only view. We know what's happening. Nobody pays the least bit of attention to Spaccy's nonsense - except the people who feel it needs to be endlessly countered, thereby prolonguing the shelf-life.