Member Info for Doc.Daneeka

Timelines next year will be critical though. I've no idea how long the cash will last but on the positive side the P2s are not going to be expensive. We have to hope they complete by the end of winter '24 and that the data is exciting enough that the P3 becomes a reality and Synairgen is able to retain control. If the P2s show a strong signal we'll be back into the 40s, 50s and well beyond. At which point the company is a going concern again and should be in position to attract a sizeable injection from one of the interested parties to finish the job. That'll come at a cost but it won't matter as the whole project will be back on track.

We know what the alternative is. If the trials don't succeeed and lead quickly to a P3 it will be the end of the road. That's not negative but it'll be the hard financial and scientific reality we all have to accept. Hopefiully in year's time we're waiting for the P3 protocols and sitting in the mid 50s.

Whatever else our concerns might be - there really is a "Concrete" plan Mani. We know what they're doing and how they're planning to get the extra data and have to hope the money lasts until they do. The sp won't re-rate significantly until we have the results of the P2s.

"The reverent" Fruits ? I mean if pedantry is the game - as it usually is with you.

Ah that's sweet - you kept that one Tommy. I can't be bothered to look for the context which would show your own unpleasantness, but your language in this post shows it was probably well deserved.

cheerio old chum - you're in the bin

Tommyd you invited Sakura - who hadn't posted since mid September - to the party at 8pm on Thursday and she duly turned up yesterday. You orchestrated a day of bickering in order to gloat and abuse Sakura. If that satisfied some bizarre craving then I hope you are sated.

Bizarre behaviour Tommyd. Bating the very occasional poster Sakura into a response yesterday evening - and then after getting the requested and predictable response - spending all day abusing her instead of celebrating the purchase of 60k new shares.. I mean why do you give even half a f.uck what she thinks and why is it so essential to your upbeat response to the decent presentation.

You should be celebrating your good fortune instead of opening up petty old wounds. Grow up.

My feeling about the COPD data is that if it underpins my continued faith in the drug - it erodes even further my confidence in the company that left this stuff in the fridge for 3 years because it couldn't walk and chew gum at the same time. How useful might this have been if it was revealed during the pandemic when there was cash in the bank to exploit it and before the meltdown. Arriving now as it does, it's a small building block for the future - but nothing more.

Reading the runes for good or ill is often the primary business of this bb, and posts are invariably as unbalanced at each end of the scale. Joseph Colliver's arrival does not mean news is imminent and deals about to be struck - but neither does it suggest anything negative about the previous long-serving incumbent's capabilities (altho Doc83's reminder of his poor responses at the AGM is well noted)

We had a CFO. He's gone, and a new one is coming in. That's neutral. Nothing to see here except the mildly positive fact that the company is still operating properly.

Quite a bit of it IS new Patagucci - at least the way it's presented, and it would be very odd to not RNS the peer review of the only successful trial since manic Monday. I'm sure they will rectify this at the earliest convenience, if the computer will turn on.

Interesting suggestion that a shorter dosing period might be worth looking at. ( given that by day 8 everyone was in hospital or not going to hospital ) 14 day treatment cycle has always been an achilles heel for me in the world of 4 and 5 day treatments. Not that it will matter in the specific cohort this is eventually targeted at - as they will already be in hospital.

Thanks Jint I couldn't see this in your posted summation - but perhaps it was included in the joint account which i think Doc83 or Wigster gave.

What I did find in your notes however, more than answers my questions. Not sure how I missed this at the time, but nobody else has quoted this in the recent conversation so perhaps I'm not the only one who should have paid more attention.

" 2) Test sets for the new company sponsored Phase2 trials, question was asked is Thermo Fisher going to be used, they stated no, they were going to use tests/assays developed by Casanova but manufactured by a company they refused to name. They stated the test kits were not generally available.

I took this to mean that it was a small run of test kits being supplied to Synairgen for their required purpose.

To this end Synairgen need/see these kits are what they require and the Manufacturer (licensed Casanova IP manufacturer) require in field use.

Over a long period it appeared that Casanova’s work on autoantibodies and Synairgen’s SNG001 had mutual benefits for both.

Furthermore, it was mentioned bio markers would be utilised along with high viral load readings. RM went on to say that high viral load readings don’t in themselves necessarily mean that the patients own INF response is lacking but it gives a marker to test further for those whose INF response is not as it should be, that’s likely where they’ll step in with SNG001 intervention. "

It'll be very interesting when we discover exactly what has been designed to study the UNIVERSAL data and provide the templates for the P2s.

I'm now going to take a leaf from your impressively understated book and take a break - hopefully until the trials are announced. Tested positive for covid on Saturday and having a much worse time of it than with my previous encounter in late 2021. On the mend already but had a couple of really tough days. My booster only in my arm a week before it came on and perhaps not long enough to give full protection but it was still surprising, given how mild my last dose was. Anecdotally it's all over the secondary schools in my West London area neighborhood and the students are all just carrying on without tests and without isolating. Fine for them of course - but not so good at a societal level. Of course the booster has only been extended to +65s and those with vulnerabilities and there will be quite a few at risk between the 50-65 cracks..... We'll see I guess - but hopefully the numbers will start to reflect the true scale of the outbreak and the Govt will extend the boosters to 50+. Take care all. Will see you on the other side

Do you know where the 300 figure came from Jint . ? Spacman mentioned it and it was the first I'd heard of it.

You're right for sure Fruits - there's nothing else going on except UNIVERSAL. Confused by the proprietorial language in the RNS which under the heading Operational, says ... "Conducting non-interventional preparatory work to expand hospitalised patient populations for potential treatment with SNG001 " when of course Synairgen is doing no such thing. Synairgen is conducting nothing. The trial belongs to Southampton Uni with Synairgen listed as providing "support in kind" ( which we know to be testing equipment and nursing support) So if this does relate to UNIVERSAL it's highly inaccurate wording.

Please feel free to respond to the substantive points in my post.

Billy - answering here to try to kill the other thread.

AFAIK we haven't had anything from the company detailing what the bio-marker tests might be. But the RNS told us for the first time which patient cohorts they're after

"Conducting non-interventional preparatory work to expand hospitalised patient populations for potential treatment with SNG001, which are likely to include: ventilated patients with confirmed viral pneumonia; and patients who are unable to clear virus and become persistent viral “shedders”, a majority of whom are immunocompromised. "

We didn't know anything about this non-interventional phase which is ongoing and must complete before the P2 trials can start. We can assume they're well advanced but as Aether says there must be a chance of further delays as this data has to be crunched and used in the trial design.

We know they have good data from the COPD trial showing viral clearance - so maybe they can reverse engineer from that - as long as the samples are still held.

And then the question remains of how you find the patients in each of the cohorts that will benefit most from SNG. If you're only trialing 30 the identification has to be absolutely pinpoint. Presumably they intend to give SNG before the viral pneumonia patients are ventilated and earlier in the cycle for the immuno-compromised patients. Otherwise there's nothing clever about it at all and no need for bio-markers as the evidence is just there in front of you.

If you had the money - despite what RM said about not rushing into a big trial - maybe you would just run a blinded trial in all ventilated viral pneumonia patients and immuno-compromised shredders. That's a small and pretty precise cohort anyway isn't it ? The "niche" I was talking about - as only a tiny fraction of viral pneumonia patients end up on ventilators and although 2% of the global population is immuno-compromised only a small fraction of this group will be so badly affected (CEV-1) that they can't mount any natural viral defence.

Would be useful if one fo the medicos can shed light on this.

What diagnostics is Synairgen employing and why have they only now informed us of the "non interventional preparatory work" that is underway.

Nah Fruits - they're just stuck fast along with the rest of us. Deeper pockets to stand the loss if it comes to a wipeout, and deeper drawers to salt the shares away in, against a future date when a return is possible. They topped up and lost even more after Sprinter - perhaps hoping to send a signal that would buoy the price - but they haven't bought any more in the bargain basement we're now in.

They might be the canniest abd brightest investors in the firmament but Sprinter put their lights out just as it did yours and mine. None of that matters anyway. The company has to find a way of somehow proving the drug beyond doubt in the next block of tiny trials. Converting the promise of the deep dive into the proof that pharmas and regulators are asking for. Everything else is for the birds.

My main concern is that the technology they talk about to identify the patients for these mini trials may not yet exist - which is what Sakura was talking about a couple of days ago. One of the main conclusions from the first 100 patients through UNIVERSAL was that " Novel biomarkers which predict severity, recovery and LOS, as well as novel therapies for acutely unwell adults, are greatly needed. "

So the observational study from which they're taking important pointers for the P2 designs is saying - " we don't have the tools to id those patients at greatest risk as accurately as we need to " Not sure how much it reads across and of course there's more to come from UNIVERSAL but this may be why the timeline has slipped a couple of times. People talk a lot about Casanovalabs as if they have the magic potion - and I'm not skilled enough to know it they do, but it seems odd that UNIVERSAL has already made this conclusion.

How was Christmas Tommy ?

Thanks Nessa " It's very important that we don't just rush at doing the next clinical trial" Forgive me, but, hahaha.

Doc83 last chance saloon is right I'm afraid. Of the many errors that have plagued the company since the success of SG016 - not attempting to collect samples from the most important and only large scale trial in the company's history is the one that matters now. That data analysis would have underpinned the work they're now planning .

Confirmation of intention to treat ventilated patients is significant - even if it was trailed in general terms after the AGM. Synairgen knows that viral clearance continues long after it initially imagined it would at the time of SG016. And it knows the drug can be delived safely to this cohort. I think it probably also knows that the COPD and RSV game is up - with several new treatments authorised or approaching the end of trials. So it's going to be niche niche for patients who are unable to clear their infection

" Conducting non-interventional preparatory work to expand hospitalised patient populations for potential treatment with SNG001, which are likely to include: ventilated patients with confirmed viral pneumonia; and patients who are unable to clear virus and become persistent viral “shedders”, a majority of whom are immunocompromised. Subject to this preparatory work and regulatory approval timelines, trials are anticipated to start in H1 2024 "

Timeline slips again - interesting that they're prepping to treat ventilated patients - which I don't think they've done before.

Https://www.synairgen.com/media/interim-results

Always thought of Synairgen's LC data as a useful add-on to help sway the case when presented in addition to the deep dive data from Sprinter. If Omicron had continued anywhere near as dangerous as Delta - where almost all of the P3 data was collected - then this might have been the case and we might already have seen an EUA - even with Dexa putting out some of the inpatient fires that were identified in SG016. As it stands now it's still a useful piece of data but the best bit of it is the 61.4% RRR for loss of smell and taste - and that is no longer a significant symptom with Omicron.

And LC has been shown in many studeies to be nowhere near as much of a problem with Omi patients. Those still suffering the worst efects of LC are still Delta patients who caught the virus more than 2 years ago. Not all of course but an overwhelming majority

Clearly if we get through the next 2 sets of trials - P2 and P3 then LC data will again be relevant in the Covid arm at least but as a serendipitous addition rather than a game breaking stand-alone. This being self evident by the fact that S

NG hasn't been EUA'd

Omicron scuppered the at-home hopes we all had after the success on Activ-2 and then SOC improvements scuppered Sprinter. Omicron is the main reason why the whole Synairgen programme is so far down on the back burner. We need a year zero event to reinstate the drug for Covid at least - and have to hope that all the other trials of respiratory disease vaxes and mabs do not turn the focus any further away from our Ifn for RVIs in general. Interferons work - undeniably - but apart from the single trial that pulled us all in in 2020 the numbers just haven't been decisive.

https://www.science.org/content/article/people-catch-omicron-are-less-likely-get-long-covid#:~:text=And%20infections%20now%20carry%20a,whose%20patients%20are%20overwhelmingly%20vaccinated.

man - that bangles track h4r - have to confess i came in on the second verse with the rest of the backing singers. **** it if i squished their 35 year old harmony -sure they won't mind. in a minute i'm going to the end of the garden to what we call the shed and blasting the chorus. see how many of the words i remember

sorry everything still hurts - but come here whenever you like - there's always room.

try not to be so hard on the oldsters though - they're the only ones left with manners in this ****show and even if they might possibly vote tory - they definitely won't take your head off with a zombie knife.