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It’s a good question migs. Personally I don’t think the results will be as astonishing as phase 2, because I think the standard of care has improved so much doctors now understand this illness and fewer people are dying because they are getting better care. So the comparison may not be as stark to SNG - assuming hospitals are not completely overwhelmed with the Christmas bump :-(
However I believe SNG001 will perform well again because we know the science works. We are not treating the symptoms of disease we are getting right to the cause the disregulation of the immune system
All the science supports the fact that it works, I think the placebo arm will perform better but the difference will still be good enough to get rapid approval.
Good point Gollum. On that old RM presentation for share magazine, RM was quoting examples of takeover prices, it’s interesting to see what was in his head.
The examples he chose were:
Phase 2 TO - $1.25bn
That’s our current phase 2 stage. A $1.25bn TO for us would be approx £5 a share
Post approval TO - $8bn deal
For us after approval that would be approx £29 a share.
Just for interest.
Here’s the presentation if you haven’t seen it, worth a full watch, but these figures are around 13 minutes.
https://www.reddit.com/r/synairgen/comments/jeyce4/richard_marsden_ceo_synairgen_sng_at_shares/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
Hi Gold,
There is nothing to lose in emailing the PM, it may help. I think they know all about SNg though, Hancokc mentioned SNG in the commons after July results and lots of members on here have written to their MP’s.
The most impactful thing we can do to help SNG is to post on our own social media about the home trial. RM said that investor friends and family had provided lots of patients for them and he was hugely grateful.
https://www.covidtrialathome.com/
Hi Tyla, in the placing RNS they said Akron biotech was scaling up for commercial supply, I believe the second manufacturer is in addition to that. And fairly reasonable for an unapproved product where all manufacturing is at risk. I think we will know more when the RNS lands shortly. We can probably assume that this issue is top of the list for SNG.
Morning all and happy new year,
It’s surprising that the covid vaccine got global support and funding from governments, yet the delay for the UK, and the rest of the world, is the glass vials. Here’s JVT:
Professor Van-Tam said: “The only thing that is going to slow us down is batches of vaccines becoming available. Many of you know already that it’s not just about vaccine manufacture. It’s about fill and finish, which is a critically short resource across the globe.”
Even the well funded vaccines can’t get round this issue, so where does that leave litttle SNG? Here’s what they said in the placing RNS:
“Synairgen has also partnered with Catalent Biologics to support the drug product fill/finish of SNG001 at its Brussels, Belgium facility where it will conduct manufacturing scale-up of the drug candidate into pre-filled syringes.”
Then in the webinar (sharesoc I think), RM talked about the bottleneck for glass vials. They were on it.
Last week, Synairgen advertised for three new roles to oversee the for supply chain and manufacturing and scale up. As part of the job advert they said this:
“ SNG001, interferon beta-1a nebuliser solution, is currently presented in glass syringes (PFS). Commercial manufacturing of SNG001 in PFS is being performed by Catalent. We are also evaluating the use of blow-filled seal technology (BFS) at Catalent.”
Researching Catalent, it seems one of their specialisms is BFS for nebulised inhalation drugs. They are also supplying BFS for AZ, J&J and Moderna vaccines.
Oh and by the way, their BFS technology centre is in Woodstock Illinois. Another part of our supply chain in the USA. Coincidence?? There is so much going on behind the scenes at Synairgen. I know it’s hard to be patient, but I believe there is a monster RNS coming that will be a pleasant surprise at how much thinking and progress the team are making behind the scenes to get this product out.
Here’s the source articles. Have a look at the BFS videos on the Catalent site.
Shortage of glass vials globally
https://www.google.co.uk/amp/s/inews.co.uk/news/health/boris-johnson-normality-easter-hit-vial-supply-issues-vaccine-roll-out-814248/amp
Synairgen job vacancies/BFS at Catalent
https://www.synairgen.com/contact-us/employment-opportunities/
Catalent BFS technology and respiratory Nebuliser solutions
https://www.catalent.com/expert-content/inhalation/catalent-solutions-for-inhaled-medicines/
https://www.catalent.com/specialty/inhalation/blow-fill-seal/
Finally Catalent are already working with operation warpspeed, what a great way for the USA to ease the bottleneck for both vaccines and treatments...
https://www.catalent.com/covid-19/
Hi Riseup, is there anything in your broker account that can help? On HL I can see how much I’ve spent in total and I divide it by number of shares, then don’t bother about the tranches I have bought (there are many!)
The trial sites are designated research hospitals. When covid sufferers are admitted they are offered an experimental drug, it’s up to them if they join the trial. They are already at a moderate stage of the disease and breathless, if it were me I would take anything that may possibly help!
Activ2 alone could double the share price here. The market views SNG as a tiny company slowly developing a single use drug for a receding pandemic in the face of a magical vaccine. It would be a bolt from the blue if/when US announces SNG (a broad spectrum antiviral) is on Activ2.
When Eli Lilly joined Activ2, there was a data review and EUA in 6 weeks. The market knows Activ2 is the ultimate fast track and the share price would immediately rerate.
Morning Alphageddon,
There is some evidence from phase 2 that patients recovered to normal activity levels after taking SNG001, they are also revisiting phase 2 patients to see how they are doing months down the line. But there hasn’t been a trial yet on long covid sufferers.
The science suggests it should work. Long covid is an autoimmune condition, so the interferon beta should be able to orchestrate the immune response. Long covid is a huge issue and RM and the professors talk about SNG being useful here. I believe the first step is to show efficacy at 60 and 90 days in the p3 trial ie patients fully recover with SNG001, then further work to show it can be used as a stand alone for long covid sufferers.
I don’t think any other drug is showing promise in this area because monoclonal antibodies attack the virus and antivirals stop it replicating, but how will those help when the virus has gone?
Professor Wilkinson said they are working with the Leicester NIHR (the specialist long covid research group) so watch this space!
Hi Smokie, 100k treatments a month is the current supply so I would expect preorders for that volume. The preorder revenue can be used to ramp up. Alternatively operation warp speed has funded and eased production for other products.
SNG has recently advertised for 3 new roles to oversee production and supply chain providers, and they also mentioned a second supplier for commercial supply. I would expect to hear more about ramp up in the next RNS we are all waiting for. I think SNG are already on with ramp up. It’s a difficult balance when they haven’t got approval yet, so all at risk. From the last Placing they invested £33m in scale up.
Hiya Al, I don’t think they are given it during the trial but if it gets EUA they can go back and dose the placebo group if they think they have been disadvantaged eg long covid.
They are going to do that with the Pfizer vaccine I think, which is a tricky ethical decision. You want to protect the placebo group, but you can no longer test the longer term safety and efficacy of the vaccine group without a comparator.
Hi Spinnaker, I don’t know what will happen with global p3, I suspect it will go faster in some parts of the world than others and that will carry us.
Personally I think we are on Activ2 and that will begin in the next 2-3 weeks. It will fill fast, be reviewed fast and EUA will be forthcoming. That would probably happen before p3 has finished in my view.
Thanks PMJH for the clarification on top 15 pharma. RM wants someone who can take on a global licence with respiratory expertise so that will narrow down the target list considerably. Those companies will understand the science here.
Lots of posts today questioning where the revenue is coming from, let’s recap:
1) covid treatment
There were 189k cases in the US yesterday. That means just one country could use one month’s supply of SNG in one day. Hopefully the vaccine will dramatically reduce global cases but they won’t be zero for the whole world, ever again
2) long covid treatment
The science tells us that SNG001 should prevent long covid. We are going to prove this in p3. The estimates I have seen of long covid prevalence is 10-20% of covid sufferers. So for 81m cases that’s at least 8m people suffering right now, not to mention future cases.
3) government stockpiling
SNG is a broad spectrum antiviral not purely a covid treatment. We k ow more pandemics are coming, we don’t know what the virus will be. How much would governments pay to avoid the economic catastrophe of the last year? Just one country stockpiling enough for 1% of their population would make this enormous revenue. And it won’t be just one country. They could spend just the cost of one day on this pandemic to ensure they are covered for any viral threat on the future.
4) licensing deal for Brad spectrum usage
SNG are currently going through a process with a third party talking to the top 30 global pharma to negotiate a global licensing deal to develop this. It’s going on right now. Upfront fee and % future revenue?
SNG will sell as much as they can possibly make. The share price will be limited only by how fast and far they can ramp up production.
Good luck all.
I just dropped in to say Merry Christmas to all my friends on here. Thank you for sharing your great research. And here’s to a fab 2021!
(And don’t bother replying to that cretin, he’s really not worth your time!)
Merry Christmas everyone!