Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
An RNS telling us P3 has started and the first patient's been dosed on the back of Friday's success could easily fly this past placing price. I don't think £2 before the year end is unachievable in the slightest and I actually think it's more than likely we'll see higher than that.
Cheers Ghia.
I agree with the long Covid data being more of a supplement to our Phase III results than something we actively have to wait for. I for some reason had a momentary lapse in concentration where I thought we'd have to wait for both sets of results but that surely cannot be the case. The primary endpoints being met will be what the world are waiting for.
I also agree with the fact that we'll have had orders and will be shipping product long before long Covid results get published and before peer review, but that data will be lovely to have at some point in the future.
Thanks Ghia, great info.
If the data will be unblinded 28 days after the last patient's dose and they're not going to wait until the long Covid arm completes, does that mean there are two parts to this Phase III with the second part being the long Covid study which addresses the data at 60 and 90 days? Or is the data being unblinded after 28 days just for an independent review to assess for EUAs etc, and we will just be getting the one set of Phase III results after the entire thing's been analysed? I was assuming the latter.
Phase III expedited with IND clearance, the lower dosing arm of the trial eliminated, the trial being shortened from 900 to 610 patients, and inevitably quicker results incoming. Even though secondary endpoints include Long Covid follow-ups at 60 and 90 days, we're still now looking at an accelerated time-frame for results.
Synairgen state, "both primary endpoints will have a 90% power to detect a statistically significant effect of SNG001 compared to placebo". That's a high probability of statistical significance and we can be rest assured that this may serve us very well come results day. Make of this what you will.
I suspect this is only one of many RNSs which will be incoming now. I predict another one very shortly before the year ends telling us of the first dosing occurring in the UK. Hopefully this gains traction in the media and we can have a justified re-rate very soon. Home trial results will be the next bit of major good news with "recruitment and dosing now progressing well", along with FDA EUA if all goes well I think.
To all of you who held, well done. And to our friends across the pond, good luck to you all today. I think the days of sub £1 are over, but a buy at these levels still seems like a bargain one could only dream of. It won't be at these levels forever.
Very interesting golf! Something happening over there I think yeah. I've looked into it and that board seem like a decent bunch too haha.
I'm all in here though because I think the rewards I'll get from SNG would be far higher than anywhere else in my opinion. I'm happy to hold and see where this takes us. News is imminent here. Now for that P3 RNS!
Beforegolf, don't worry. I thought the cross post was highly relevant here. A rise on no news sounds peculiar but may be related to the recent news of TYK2's involvement in Covid-19 exacerbations? Just a hunch. Anyhow I wish you the very best of luck with them.
Patience and patients needed indeed. I'm sure we'll be taking off very soon and we'll hopefully be in our rightful place as one of the most effective therapeutics for not only Covid-19 but other respiratory conditions in general.
Scinv, I absolutely agree. We know how valuable the role of interferon is, particularly in the early stages of disease. There's plenty of evidence that points to it helping a lot of people if timed right due to interferon's broad antiviral properties. But your point about those that do have a deficiency in interferon function highlights that there are markets within markets that would likely benefit from SNG001.
Beforegolf, thank you for the heads up. I've heard of them but I need to read into their work. They sound extremely interesting though. Their work on TYK2 couldn't be more relevant at the moment - there are a lot of drugs with anti-inflammatory properties they can work with in this area but I suspect it'll take a bit of time jumping through the hoops with the red tape that comes with researching them all. SNG have a few more small hoops to jump through but we could provide the answer that a lot of people are looking for very soon.
Millie, yes it certainly puts the precision medicine comment into context. As far as I know Baricitinib is the only treatment that may be effective in situations like these which opens the door wide open for other new treatments to come along, and what better treatment than one that's about to start a Phase III trial. Surely we'll be at the front of the queue before long. With SNG001 being as innovative as it is, I'm confident the world will wake up and the science of therapeutics changes rapidly on the back of our success. We may well be the drug that gets the ball rolling in so many different areas of medicine.
So I've been doing some more reading into the genetics involved in Covid-19. It took me a while looking into this and typing late into the night means I wasn't thinking as straight as I should have been so forgive any spelling mistakes.
New research has coincidentally highlighted malfunctioning genes that may provide an insight as to why SARS-CoV-2 affects some people more than others, and why treatments will need to sit right alongside vaccines in tackling this problem forever, especially in niche situations such as people genetically susceptible to the severe illnesses that Covid-19 can cause. Fives genes have recently been linked to severe illness with this virus: TYK2, CCR2, DPP9, OAS1, and IFNAR2.
1) TYK2 - a gene involved in anti-inflammatory response by way of signalling cytokines and thereby powering inflammation which can actually damage the lungs in high amounts, such as in the case of malfunctioning TYK2 genes sending the immune system into overdrive.
2) CCR2 - another gene involved in the immune response by way of acting as a receptor for monocytes and macrophages.
3) DPP9 - another gene involved in the immune response.
4) OAS1 - a gene involved in antiviral responses by way of viral degradation and blocking viral replication, and therefore preventing viral spread.
5) IFNAR2 - another gene involved in antiviral response. This gene helps build the receptors on cells that allow interferon to bind and therefore prevent viral spread within the body. It therefore helps produce interferon which helps trigger an immune response to viruses.
Paying particular attention to the last two aforementioned genes, it can be easy to see the need for a drug such as SNG001, especially in the early stages of Covid-19 infection in patients with genetic predispositions to severe exacerbations. If JAK inhibitors can aid people with TYK2 malfunctioning, then why can't interferon treatments help those with OAS1 or IFNAR defects.
You might think vaccines could eliminate this problem anyway, but think again. If a patient's very own genetics is stopping itself from producing those sufficient immune responses against this virus then would vaccines be the one and only answer in those patients? Or would a novel treatment may also be required to target the very thing that's keeping those patients from fighting against this virus? Say, an effective, safe, and familiar treatment that gives those interferons back to those patients?
I wonder where we'd find a treatment like that from.
Scinv, goodness me.
Your first point wasn't said anywhere.
Your second point was the point of my post.
Your third point wasn't said anywhere either but you've jumped the gun a bit. That wasn't implied anywhere in my original post.
Your fourth point on the variants in question needs some background reading on your part, go and have a read and let us know why we've heard about them - a little hint, they haven't just 'stood out from the background' for no reason. One of them is the predominant variant in multiple continents and the other was responsible for the second wave.
And lastly, nowhere did it say that people shouldn't vaccinate in that post.
Please read the posts properly before replying or don't reply at all. It wastes my time replying to embarrassing posts like yours.
The virus will unfortunately become better at evading vaccines if the vaccination roll-out isn't done properly the first time around. Just to explain this a little further:
Professor Whitty tried to answer a question on Monday regarding vaccines and whether they'd have reduced effectiveness against VUI - 202012/01. He said that because a vaccine isn't being widely rolled out yet then there's minimal 'selection pressure' on the virus, meaning there's no pressure for the virus to mutate to try and get around the vaccine as a vaccine hasn't been properly rolled out yet. Which led me to ponder the possibility of selection pressure becoming an issue in the future.
As with any new vaccine, there are always the usual teething problems such as supply of the vaccine not meeting demand, portions of the population not opting for the vaccine, and the vaccines themselves not providing immunity for long enough in the people that do opt for it. These scenarios increase the risk of selection pressure as the scenarios allow the virus to hop between populations and learn how to deal with hosts who are becoming more problematic for their replication. It's becoming more of an issue this time around as we're not yet prepared enough to deal with the consequences of problematic selection-pressured variants - should they arise. Small orders for vaccines, populations already refusing the vaccine, and allowing populations with comical levels of common sense and differing immunities to repeatedly mix. We now already know that the new N501Y variant has attempted a pretty good job at mutation, enough to have itself investigated as a matter of urgency. Even though it doesn't sound concerning at the moment, the fact that it's been able to undergo selection pressure this quickly is evidence in itself that the system currently in place is either not efficient enough, not working, or both.
Governments will have to follow the path of least resistance sooner or later. I'm confident that in the very near future we'll have made enough progress with P3 (UK/US arms at least), home trials, and likely EUAs, because SNG001 sounds like one of the best answers to problems like selection-pressured variants.
News will land soon. SNG001's time is coming.
The line that says "preliminary research suggesting there are reasons to be concerned" says it all really. Several mutations present already and it didn't even take long for this to happen.
With insufficient herd immunity, governments lifting lockdowns whenever they see fit, and swathes of the public lacking basic common sense and hygiene, there is indeed a risk of many more emerging in the future. Worrying.
Hold, that thesaurus comment made me laugh. I think promising a P3 start in 'two or three weeks' must have been based off of the trial already being set up for the most part.
Just a couple of relevant quotes. Parexel's senior vice president Graciela Racaro said that "there is a distinct sense of urgency in the race to find a treatment, and working with Synairgen we are able to support a study of their novel inhaled therapy". RM himself then said that there's a "clear need to ensure a smooth, fast and successful trial".
I'm sure both companies are aware that speed is a factor in these trials and RM knows that time isn't on his side. He'll be doing everything he can to start this as soon as possible and I have a feeling it's already set up and raring to go. Matml's timeline points to this too. I'm sure we'll get that RNS this week, and if not then next week latest.
I agree Hold. This bit of news yesterday basically highlights that genome sequencing and virus surveillance needs to continue so that any virulent variants are caught and preparations can be started early. It's already worrying that the vaccine is only a few months in and it's approved, especially if vaccines take up to a year or two minimum to get approval. So for the vaccine to then get changed again in the future, they need to ensure it stays safe for all that take it. Especially if combined vaccines enter the conversation at some point like you say.