Aether, fair enough but I'm still open to holding this long term for a significant return. All we need is an EUA, albeit easier said than done :-). For transparency I own 3x more shares than I did pre sprinter read out and have put cash aside for further price wobbles. After all you have to be in it to win it. GLA
Hi Axe C, do you mean 30th of April? If so please could you share your reasoning. I would have thought Sprinter DD data will be released on the day of ATS conference or a few days before at best.
If you meant 30th June then that is the cut off date for receiving Activ 2 phase II data.
In reference to the ATS conference the last rns stated the following:
"The analysis will also include an assessment of the data in respect of high-risk patient populations, such as the elderly and those with certain co-morbidities".
Is it possible Synairgen could apply for an EUA for use on these specific High Risk patients? I think it is plausible despite zero mention of an EUA application post the sprinter results from RM.
You'd think the high risk, hospitalised patients market would be worth alot of money especially in the States.
For use on all other patient categories we might then have to wait for more data to get an EUA. This would require the previously mentioned larger platform trial to confirm statistical significance on the reduction of progression to severe illness / death.
Any way good luck all and stay patient!
Trinityman, good post and it summarises much of what many of us have been thinking / posting.
IMHO its time for the company to grow up, time to get real. I do have a comment on your following point though and I hope you dont mind me requoting you:
"This is new ground senior clinicians, investigators and indeed ourselves as individual retails shareholders are all covering together, but the product that underpins your investment is sound and has commercial value, of that there is no doubt".
I actually think there is serious doubt and hence the share price is where it is at. Put bluntly we need statistical significance. I don't give a f*ck about what science suggests its all 'talk'. It's crunch time. The Synairgen team need to come up with cold hard facts to get an EUA. Their attitude should be where there is a will, there is a way. I dont care how they do it, just do it. No excuses. We are all obviously 'hoping' they come up with the goods from the Sprinter deepdive.
However, I imagine there are bigger fish than us that have told them its non negotiable, just get it done. Good luck all.
Ps. For what it's worth I think this looks a great investment opportunity at these levels, but it is not without risk especially if you require an element of liquidity.
Joey D perhaps, but that is pure speculation and I'm not sure investors would have approved of that stance or if that approach would be considered a 'scientific norm'. At the moment no formal statement has been made by the company. They are probably hoping they get approval and get away with the futility debacle. However, as I stated last night this could issue come back to bite from a legal perspective. Any way at the moment best to look forward not back! GLA
Richlist, I think alot of the building blocks for commercialisation were put in place after the mid trial futility test passed. Either the analysis was poorly conducted and / or SOC changed enough to wipe out statistical significance / positive effect. Everything divulged by Synairgen to date eludes to the latter point but no specific statement has been made. Listening to last weeks interview the team were obviously as shocked by the ph3 result as the market. It would be interesting to know how frequently futility analysis passes in clinical trials, yet the trial misses all end points. As we have found out it's an expensive problem in R&D.
Moving goals posts hey. Yep. Didn't beforegolf report that RM told a large, long term shareholder the review would take two weeks on the day of results. Bloody long two weeks. Still to be fair alot to review and distill....so benefit of the doubt given for the time being. GLA
Tommy, in response to your 17.40 post I'd generally agree. However, Re 'Frustrations', I would say Synairgen are in a precarious position as if they fail to deliver (ie get an EUA from the Sprinter deepdive) and this goes really south I could envisage large shareholders initiating litigation over the the futility test being passed. Now Synairgen BoD might be entirely blameless but it is a risk which could emerge. Its the sort of issue which could hamper M&A / takeover activity with legal action pending.
That is true Manifesto! However, I think they should have reconfirmed their intention / ability to apply for an EUA off the back of deepdive (having missed trial end points). Let's hope some of the big shareholders are in their ear about doing so, if the data is good enough!! Probably contrary to alot of PIs who would be happy just to recoup paper losses, I'd prefer to see Synairgen commercialise the drug or undertake a JV to do so even if it takes 2 or 3 years, rather than selling out to big pharma.
GLA
Tommy, Kevin,
I agree with your points. There are so many unanswered questions. A few key ones: what was the impact of steroids on those receiving SNG001 in phase 3, why did the futility test appear to pass then end points fail, when and how will the long covid data be released, what is the strategy for commercialisation. To date RM has insinuated further platform trials and no mention of a potential EUA if the sprinter deepdive provides meaningful data. Not good enough. In my opinion statements on all of the above should have been made by now. I think they could sharpen up communication to the market.
That said, I still think this is a compelling investment opportunity at these levels and have been adding. However, I have put aside cash to take advantage of any further dips. GLA
Given the amount of shares he has his salary is immaterial relative to the rewards he will receive from the success of SNG001 getting to market. He is very well incentivised and aligned with shareholders. IMHO, the only quibble one could make was his cash bonus before the job was done. GLA
That's right Manifesto. I reckon they're in for £1.20 at the absolute minimum at the moment, and my guess is they're holding back the ability to buy another c.a. 4.9% if there is a sell off to 10 gbx. Only then would they have an average price of a quid. GLA