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The EUA application will look at all data available.
The Activ-2 data will add to the data from Synairgen’s own home trial and phase 2 and 3 studies.
I would imagine this data will be used to determine safety and efficacy but also the settings in which the drug should be used. Without Activ 2 support I don’t think we would get any sort of approval for use outside a hospital setting.
Others on this forum will recall the steady decline of the SP before phase 2 results were released.
It’s nothing to worry about, just a bit frustrating that you could have made a quick profit had you sold yesterday and bought back in today.
I don’t know why I even bothered to click the link because I knew the article would be rubbish, but even by their standards this is bad!
https://www.fool.co.uk/2021/10/20/the-synairgen-share-price-jumps-should-i-buy-the-stock/
“Worst case scenario that Synairgen could run out of money and cease to exist!” Shame they didn’t look at the balance sheet last month but even then when you have a treatment with the data behind it that ours does, liquidation isn’t a worry. Ridiculous stuff!
There will likely be some complainers but in have no problem with the Options being issued as per RNS.
Synairgen have been recruiting top professionals who have great experience with much bigger firms. We’re never going to be able to compete with potential salary so this is obviously the way to attract them.
Synairgen have told us previously that they’re in regular discussions with governments and big pharmaceutical companies.
I don’t think Synairgen will be in any immediate hurry to sell, not when they’ve made it this far on their own. So I would say the ball sits with in big pharma’s court. If they want SNG then it’s up to them to make an offer which can’t be refused.
Success in either of the P3 trials will only push that price higher.
It wasn’t a target as such but was in the placing RNS or another released shortly after.
They still could have left it to talk about 10k or so treatments being produced and peddled out lines about supply etc. Instead though they’ve qualified it with government support. Unless you have government support, or expect government support, I don’t think you would put that on an official presentation (particularly when you’re working closely with a government and don’t want to p*as them off!)
It’s also why I think they are so relaxed about the timescales for finishing the Sprinter trial.
While we are all bemoaning delays, I suspect the Synairgen guys are remaining calm because of contact with the authorities and knowing that it’s better to wait and finish the trial properly than rush and miss a once in a lifetime opportunity.
That is just solely opinion though.
There is a lot going on with Synairgen in the states and the evidence points to ‘when’ not ‘if’ big news lands. There are the recent appointments, Castro’s slip and the application for EUA when the time is right.
One thing I thought was interesting, which was slightly overlooked on this board, was the mention of Synairgen being ready to produce 10’s of thousands of courses upon EUA being granted but up to 100k with government support (on the slides presented by RM).
Maybe I’m reading too much into it but it’s a strange thing to publicise if conversations about quantity haven’t already taken place with a government/administration. Otherwise how would you know what quantities they want, what they would be prepared to pay etc. In fact, why would you even mention it at all? They presentation didn’t say they could do 200k treatments if EUA was granted by UK govt or EMA. Just feels to me like another wee nod that if/when the US govt approve this, they’ll be signing up for 100k treatments per month.
@JSP - you never know on this board!
A 10%+ rise on speculation is nice but makes you think about what will come when real news rise.
Progress to Phase 3 of Active 2 would be a great boost ahead of our Sprinter results. May also help speed up EUA from the FDA if efficacy and safety have already been reviewed by US government.
My only slight concern with Activ-2 is that it’s not the setting in which Synairgen has been shown to be most effective. Could flip that round though and say that if it’s good enough to progress in the home setting then our Sprinter trial results should be exceptional.
At the risk of being shouted down as a de-ramped, important to add some perspective.
Today was a great day if you bought in recently, but we’re still quite a bit down on the SP from before the last RNS so some people will still be staring at significant losses.
Could rise another 10% tomorrow and still wouldn’t be interested in selling. We’re on the home straight now and as a believer in the product, it’s just a matter of holding on a bit longer.