Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
Symptoms lasting longer than 12 weeks with other likely causes excluded within and shortly after that cut-off point constitutes a diagnosis of Long Covid which wouldn't be hard to identify by the clinic by that point.
Thank you for doing that Mani, keep it up.
I think most of us knew instantly how huge the news was on Monday and how quick it propelled us back onto the same stage as every other therapeutic out there that's been EUA'd (as far as I know, it doesn't get much better than 70% on top of standard of care). We've found the holy grail of the statistically significant 70% improvement on top of standard of care result. It's a miraculous result and better than anything I ever expected. I'm still absolutely shocked at how good the result is.
The SP slip is something I completely understand. Traders taking profits aside, I don't think anyone cares anymore even if our result was a 100% improvement - unless the board tell us what they plan on doing with that statistic. And a slight hint - a platform trial due to end in 2024 or early 2025 won't be the answer that people are looking for.
Wise words Skippy.
And yep, I don't think anybody's in the mood for another trial due to start in Q4 2022, finish recruiting in Q3 2023, with results due H2 2024. We're past that now and need to start thinking of how we're going to get this to those who need it.
Fully agree Axe.
Let's give them some time for the company update meeting and the AGM by which time they should have let us all know of the direction they wish to steer us back to the forefront and how they're going to do it. If we don't get this by the AGM I believe we all need to start talking about what we're going to do about the situation because I haven't come across a single person who has invested in this company who is happy with they way they've handled and communicated things over the past few weeks.
It's been a pathetic engagement with their shareholders, especially after the fundraise. I understand that they're likely quiet because talks are still ongoing and who knows what they're about (platform trials, EUA, JVs, TOs, who knows), and I'm sure we're all more than willing to give them the time and space to sort all of that out. But there's a difference between giving them the time and space and being left completely in the dark - and that's what I won't be standing for either.
Fantastic news this morning and hopefully the start of recovery for this company. I knew they had something big to still play for and a reduced risk of progression to severe disease or death of 70% in a third of the trial population with a p-value of 0.046 is worth presenting to every pharmaceutical company in the world this morning.
To those who weathered the storm on February 21st, well done. Let's get this show back on the road!
That's seven times.
People would indeed have made a few grand, I agree with you. I doubt many people would care about a grand here or two though with the amounts some here have invested. Tangible northwards movement in the SP is what investors are waiting for, the majority of which are the so-called horses that comprise this board. With regards to why some people may not have listened it's probably because it's the traders that start shouting from the rooftops on the eves of highs and lows that give the rest of us trust issues. So just trying to save you a little bit of time here with the greatest of respect.
Neigh. I mean night.
I'm admittedly partial to your posts here Andy but how many times are you going to say that, that's six times you've presented the same bizarre ultimatum in one day.
If you think it's as binary as that and all hinges on tomorrow then I'm not sure you know what you're invested in - if at all.
Thanks for the reply. Yes I did see your post last week but I must have missed when you quoted it back then. I just wanted to clarify it because in my opinion if that's been quoted then that's very promising news indeed and shows the gaffers aren't going all the way to San Francisco just to discuss the fact that our drug works in petri dishes. Thank you for bringing that to our attention - I'm astonished at why that quote hasn't gained the traction it should have.
Another quick question - which results were announced on 19th April? I can't recall anything being announced on 19th April within the last three years unless I'm mistaken.
Nice post Trinity. Just a question though.
"The on-going American Thoracic Society meeting also provides an opportunity for Synairgen executives to progress the licensing process by meeting a significant number of the potential development partners who have either expressed or re-affirmed their interest in the programme since the results were announced on 19 April."
Can I ask who said this and when?
Cheers Ghia.
This seems more and more a sensible route with all the data we now have. I can't see them throwing progress away for the sake of an inconclusive result which clearly shows it can save lives.
The Activ regime is perfectly set up for this and along with the new news of a placebo for comparator I'm starting to think there are other IIs of the same thinking.
All speculation on my part too but it's making more and more sense to me that this could be a sensible pivot for us.
Great post Ghia. A quick question for you specifically if you will.
What's your opinion on our chances of commercialisation of the product using only our combined home and hospital P2 data, Sprinter data, in vitro results, and A2P2 data?
Agree with DD.
Positive A2P2 results will be all that's needed to see this climb again and turn sentiment around at the drop of a hat. Around that time I fully suspect Polygon will have long completed their required holding and will be looking for an exit as quick as possible. I doubt they're playing the long game anymore and Doc's six-month timeframe for this story before it's passed on to somebody else may just be spot on.
A2P3 in my opinion will not be on the cards for them. Waiting for trial results for a trial that hasn't even started yet surely won't be on their agenda unless they've been told something that the rest of us haven't regarding the company's immediate next steps following a positive A2P2 readout which is around the corner. Only in that case do I see them sticking around and they'd be right in doing so.
I don't see our story being dragged out through another trial if I'm being honest. If the company don't come out with a statement soon telling us they'll be salvaging the positives and pressing ahead with what they've got then I'll be very surprised.
-Positive Sprinter data extraction
-Positive A2P2 readout
-In Vitro Delta and Omicron results
-Long Covid readout
May be all that's needed to have kept Polygon on board and if so then this may be something I could look back on and laugh about in the next few weeks to months. Need to hear from them first though - they won't be getting any further backing from me until I hear something soon.
RM's only mantra of late was getting this drug to market, short of provoking a deal or sale of the company itself. With the actually invaluable data Sprinter's given us (excluding endpoint failure and lack of stat sigs) I still think this is possible and depends on how much and how hard he wants to pivot to ambulatory use - seeing as though logistically everything has been put in place for this already and could be ready to go if they will it so.
The question I keep asking myself is whether he's willing to let everything collapse in on itself and risk doing another P3/platform trial which he knows will take time that we haven't got and risk yet another inconclusive result, or work with what we have already and refashion this entire project for ambulatory use which could come with short to medium commercialisation if things go as well as we've assumed (Molnupiravir springs to mind). With BA.2 now making up almost 4% of infections in the US compared to it having only made up around 1.5% roughly three weeks ago, the market could soon be a lot clearer for this use again than it seems right now. Endemic treatment will be needed for a long time and if we can seize that gap in the market right now then there's still hope.
Polygon and Co are in the same position as the rest of us and either know things we don't or they do not. I'm not sure how much I believe that they're merely averaging down with their moves over the past few days but I'm holding out in the hope that they want their money back as fast as the rest of us do. I'm expecting updates from the company by the end of tomorrow - they've had more than enough time to put together their Plan B speech and we need to hear it now for this ship to be steadied. If people are sitting in places thinking and feeling like their lives have been ruined they have a right to know whether there's a plan in place. People will be making decisions in their lives with every day that goes by without hearing from them so they need to speak up and they need to speak now.
Hope you're all hanging in there folks.
Yep, my thoughts too.
Two hopeful scenarios for me would be that either positive Activ news is around the corner which could show a clear market again and possible commercialisation in the short to medium term, or they'd be taking matters into their own hands and forcing progress via a different route whatever that might be (hello 30%).
Whatever is happening they'll surely be wanting their money back, and fast. Just my thoughts.
Sensible post by Tommy with whom I fully I agree. I seriously doubt they'll be waiting 12 months to see how this plays out. Whatever discussions they've likely had after Sprinter results will probably have been centred around Synairgen's immediate plans and how they intend on making the most out of the situation we all find ourselves in now.
I highly doubt a powerhouse like Polygon will be content with waiting another year to see how things pan out.
To Rob and Doc in particular, really sorry to hear you've been so low. I think we all have but it's hard to read this about fellow investors you've spent a couple of years with. Stay strong and let's weather this storm out too.
Doc - so happy to hear about your mum. Congratulations and a huge well done to her. Wonderful to hear.
Hi all. Hugely disappointed that the results have turned out this way and that a lot of us are unbelievably sitting on losses for now. I was hoping this journey would be ending soon but looks like I'm here to stay and hold until things play out again. 87% of patients given corticosteroids and SOC changes since July 2020 have scuppered things but the purpose behind this post is to highlight two things:
1) Safety profile in patients.
2) Reduction in progression to severe disease or death within 35 days of randomisation.
Having worked on the front lines throughout the entire pandemic and having seen all of the things that have happened to both my patients and the healthcare system that buckled with those very patients, one of the things you can be sure of is that we need as many treatments as we can get our hands on before the next variant or viral pandemic hits. We don't care if those treatments are oral, IV, inhaled or rectal - a vial with the label 'treatment' on it would be just fine. I was working when every one of the SOC drugs were coming into play, and the effectiveness this drug's shown against severe disease progression in Sprinter is something that shouldn't be ignored either. So for me there's light at the end of the tunnel that Richard and Co will now need to help us through. I'd be more than happy to prescribe ambulatory patients something they can trial on AMU and take home with them to finish off. God knows they can't be sent home with Dex, Toc or Monoclonals. My point is that even if it saves a single life then there's a place for it in the nurse's drug cupboards.
What could this mean for the future of the drug and the direction the company could take it in?
-progression of the development of the SNG001 product based on Activ data plus our full PII and PIII datasets?
-awaiting Activ data alone and pivoting once more for that cohort?
-new local trials for that grey area of ambulatory patients?
-further local targeted trials to investigate patients without even SOC?
-are we still EUA'able considering the specifics we can extract from the readout?
-handing over to a partner?
Who knows. Those potential paths above could be considered or they can be laughed at (I've been doing both) as they'd cost more money and time. They could take it in another direction entirely. I'm sure the board will have not only prepared for the eventuality of an unfavorable Sprinter readout but will already be in talks about where to go from here. He'll likely be aware of the damage this readout's caused to many and this wouldn't have been what he meant by 'maximising shareholder value', but I'm sure they're all working flat out to put the wheels back in motion.
I completely understand if people cut their losses and huge commiserations again to those that do, but I'm holding for the company's next steps and for the show to get going again (if it hopefully does).
I hope you're all well either way.
Over to you Richard.