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I dont disagree Docdaneeka, but that is all in hindsight. At the start they were worried about having enough participants....
In any case Synairgen have a lot of explaining to do. I want to know what the hell happened with the futility test!
They went global as they needed to make sure they would have enough participants. It's as simple as that. RM stated one of the biggest risks of the trial was not having enough participants to actually finish it!
Leroygamble, I can only assume RM has been waiting to have the Sprinter analysis to speak and it's taking longer than anticipated. Speaking without the facts could be very misleading and damaging. Mire harm than good. However, given the Sprinter review is dragging it now looks really bad form on his part.
I'd like to give him a bit more respect and benefit of the doubt than to assume he's just hiding from the cameras. We also don't know what large shareholders have told him behind the scenes. Importantly, when he does speak to the media he'll have to have something positive to announce, be able to disclose the facts on the Sprinter trial and be able to answer questions on steroids, differences in standards of care accross georgraphies, why the futility test appears to have passed yet end points were missed etc. Etc.
GLA
Andy, I just read you crystallised a 60k loss. Sorry to hear that. Don't understand why you did that when you've previously stated you're happy to sit this out and wait for a turn around.
GLA
Tattyhead61, I think he's been waiting for the deepdive data to speak and it's just taking longer than anticipated. It was reported on here he told a long term investor he thought the deepdive would take two weeks on results day.
Yes, bids might come in with an EUA, but IF that happened I suspect the BoD would go back to plan A (i.e going it alone as per the plans put in place pre Sprinter top line read out). The quality of the data underpining the EUA would also play a significant factor I'd guess... All hearsay though at the moment.
GLA
Reflecting on Beforegolf's post of a doctor's view last week, I would be very surprised if there isn't enough evidence to submit an EUA even if its pushing it. Who knows but they might already be speaking to the regulators about it.
Andy,
You made the following comment late last night to my post:
"I’d say we are better off ditching Marsden for his utter failure, starting from scratch again and getting proper endpoints to a new Phase 3 trial which simply shows % chance of saving lives and have Remdesivir and steroids as our ‘placebo’ wing. Take 500 participants, 250 in each wing. Then if we get SNG001 to have a 40% extra chance of saving lives than Remdesivir and steroids = great success."
My response would be thus:
Now I'm not trying to pick an argument, but once Synairgen remove a couple of categories of participant this description you made above of the data a new trial might provide is actually what the sprinter deepdive should / might reveal. Why run another trial when we already have the data.
Remember even with steroids and improved care, progression to severe illness and death was reduced by c.a. 36 / 37% with statistical significance of 0.11. From what I've read it isn't going to take much to shift the needle to show statistical significance of 0.05 and the efficacy might improve as well. Why is another trial needed?
Inaddition, the long covid data may or may not have be effected by steroids. We'll just have to wait and see I guess.
GLA
You'd think if the sprinter review data has half a sniff at an EUA they'll apply for one otherwise its a hell of a fund raise that's gone up in smoke (even if it enabled a bigger platform trial). As Manifesto alluded to yesterday this is where Polygon act as an insurance policy for us lowly retail investors. I cant imagine for one second they'll stand by and not pressurise the BoD to submit an EUA if there is a chance of approval.
I feel certain RM has remained silent to date as they're working overtime to pull a rabbit out of the hat and rescue the situation. The burden of responsibility must weigh heavy. My guess is the deep dive is just taking a little longer and maybe there is a lot to clarify over how the trial was conducted accross different geographies. Any way stay patient and sain. Take care and good luck x
Andy, thanks for the response. I'd like to think my post was a tad more postive than some of your recent ones though, lol!
I only see a fund raise likely if all covid market options are exhausted and I think we're still quite a long way off that yet. It sounds as if the current funds would be sufficient to run the business under a platform trial.
Re. Synairgen's ability to commercialise. There has been a huge amount of RM bashing recently, but I'll give him the benefit of the doubt until the Sprinter review analysis is out. I can only guess he's been waiting for it to make a public appearance and it is taking longer than anticipated. If the sprinter data is good (once sliced and diced) and they don't apply for EUA then I think your criticism would be merited. However, if it is good then I just don't see how Polygon will stand by and not push Synairgen to submitt an EUA. GLA
J_CIT, can a conclusion on whether SNG001 is the best or not (especially for specific categories of patient) be made until the analysis of the sprinter data is published? Throw in Activ 2 data as well and I'd argue possibly not. I'd like to see all the facts first.
This is the way I see it. First of all a loss is never a loss until its crystallised. Its also important to remember short term price fluctuations are just that. Even if 90% down. A long term outlook is critical. In times when your shares are down you need great confidence to hold and belief in your underwriting. Some muppet was on about 'group think' last night and ripping the science. Each to their own, but I genuinely think SNG001 has a real future as a broad spectrum antiviral. I don't think the said indervidual was well researched.
In terms of outcomes I think there are four:
1). Sprinter deepdive data and Activ 2 Ph II data is a bit average. Nothing really comes of the covid market. Investors either have to sell out at a loss or hope that copd etc. comes good. Maybe a profit is made but its 3 year hold minimum to find out. Maybe they try a platform trial but covid numbers peter out and the trial remains incomplete.
2). Sprinter deep dive analysis and Activ 2 data is okay, but doesn't merit a EUA application. It is good enough to generate enough interest that Synairgen is sold off to a big pharmaceutical. Under this scenario Polygon are highly influential. Maybe you break even, maybe you make a 2 or 3x EM.. some long term holders will do very well, but I would envisage the company is sold off in the 150 to 300 gbx range. Maybe even lower. However, I think the strike price will be above Polygons average.
3). Sprinter deep dive analysis, and possibly Activ 2 ph II data, merits an EUA for the reasons set out within the beforegolf's post yesterday. Synairgen out perform current sentiment / expectations and get SN001 to market. Valuation is driven by earnings / potential earning which are significant especially if approved for both home and hospital setting.
4). Sng001 gets on to a platform trial and is eventually proven successful. This might take another 18 to 24 months. The drug might get fully commercialised, but it might not if economic conditions / politics prevents pandemic prevention stockpiling.
The company could also become insolvent, but I think scenario 1 would be exhausted first.
Looking at all these scenarios patience is key and the upside still persists. The question is punk (s). Are you feeling lucky?!
I for one remain slightly optimistic and welcome thoughts on additional scenarios. GLA