Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
I still think post-sprinter. However having said that the speed at which we've got this LPD RNS out makes me think they might be revising that. I think it depends on how bad the situation gets over the pond over the next few weeks and whether the data unblinding is enough for the company to file an application before the readout.
Fruits, your question is something I've been thinking about recently. Some people on here keep plucking a very well-rounded £10 figure out but if this loads up to between £2-3 Pre-Sprinter and it rockets similarly to P2 results then it would be near around that figure quite quickly in my opinion. If we're conservative and assume it only makes half of the effort then you're still somewhere near that figure on data release alone and that's without EUAs, approvals, orders and sales. So I'm wondering why people are assuming £10 is the ultimate goal here rather than just another SP target that we're all hoping we hit along the way on the journey to it's true value.
Thanks for the replies, very helpful. My understanding was that they were in it for themselves first and foremost which would ultimately be good news for the rest of us too. Hopefully that doesn't change and they don't have any ulterior motives.
HFs and the way they operate aren't my strongest point. What could be a downside of Polygon owning too much of a stake? They're going to be passing 15% before too long so I hope it's not all bad news. I was under the impression it was a good thing having them on board.
Thanks for the replies.
Yes I'm a little disappointed in that too. A delay in P3 results is fine by me but not being EUA'd until P3 results basically means there'll be nothing to hold this SP afloat until those results land. So this will probably trickle over the next three months with no news to stop it.
Hi all. Read the RNS at 7am today (all fantastic news apart from the slight delay now) but I missed the webinar so I didn't catch what was said about EUA and when it will be submitted.
From the RNS they've said: "To ensure we can get this treatment to patients as quickly as possible, we are preparing to engage the US FDA on a potential application for Emergency Use Authorisation (EUA) and have aligned with partners with COVID-19 expertise for distribution and in-market support."
But then from the end of the webinar it was apparently said that only SPRINTER results will be triggering an EUA application. We now know SPRINTER results will be released in the new year.
So am I right in assuming EUA will not be applied for and granted this year?
Cheers for the link SD, and I heard that about the inhaled treatment too. Exciting stuff.
-"if we had vaccines, booster shots, and therapeutics, we wouldn't be in this crisis".
-"i'm a little bit worried that we're going to be in for a tough couple of months".
No specifics in the update apart from the above, pretty vague stuff aside from what's been mentioned. Fingers crossed for next week.
This has been a refreshing thread to read so thanks to all. Merchant - interesting point regarding the BioNtech/Pfizer arrangement.
I do agree with posters here. This feels a little different from the usual hype and there's far too much momentum behind this now for news not to drop any day. The amount of new research that keeps dropping every other week just keeps making that spotlight that's shining on us brighter and brighter. I can just feel the big pharmas around the world watching us like hawks.
Thanks Blessed.
I'm hopeful that "hopes to file for regulatory approval globally early next year" doesn't turn out to be another delayed date like the end of March. I doubt it though - if P3 turns out to be a success then I have a strong feeling things will start to move very quickly.
Fruits - quite an interesting comment about the licensing being able to achieve the goal within the same time period.
There's a lot of talk on this board about T/Os and i've always been confused about why people are leaning more towards a T/O rather than licensing. RM has said the words that they have interest from "pharma companies that we'll want to partner with" so doesn't this effectively rule out a T/O?
I'm not the most clued up on T/Os and licensing deals and what exactly he meant by that comment but that phrase that he said word for word in an interview categorically ruled out a T/O in my mind. But then his figures from a few years ago showing how much companies can be worth Post-PIII results suggest otherwise. Confusing! I'd appreciate any insight into this because it'd probably clear up a few things for me.
Thanks Tony.
That was interesting to read. The concept of eagle hospitals makes sense as it's usually the usual suspects that are chosen for certain trials and they're usually the ones trialling new treatments before the rest of them. That's often the case with us and we're always referring on to these eagle sites. There's clearly a system in place that we don't know much about so thank you for the insight into that - it's something I'd never really thought of.
Thanks all for the truly wonderful feedback. I was having a sleepless night so thought I'd ramble for a while. It's been very touching to read through all of these comments so thank you.
Kevinl1977, no the physicians weren't aware of SNG when I brought it up which just shows how much of a bubble each hospital is in while working on their separate respective trials, however one of the consultants in my neighbouring hospital does know about it and is working with it and makes me wish I was a fly on their walls. We can't lobby for drugs to be added to our trials. We get told by our ward managers that a trial will be starting or that we've been added to a trial but we can't actively ask for agents that we don't have unfortunately. That reminds me, I work with experimental drugs, drugs prescribed off licence and even drugs prescribed via compassionate use/expanded access, but I've never heard or seen MAP being used.
Gunto there are parts of me that agree with what you're saying. However with everything happening at the pace that it is with no telling how many future waves we'll be dealing with and the notion that we're going to be hit with endemic waves in the future due to large populations never being fully protected, I highly doubt that organisations such as the NHS are going to be deciding which treatment to purchase such as pills or nebulisers over the other. Therefore governments being influenced by companies with regards to one drug more than the other makes no difference to us. When a treatment's been proven to work then there will be demand for it. That's the way it works and everything else such as influential power needs to be forgotten. The general feel is that when effective treatments start coming along then there'll be a place for all of them, and not necessarily picking and choosing one or the other. Especially if both drugs are different to each other in terms of their pharmacokinetic properties and uses, and especially if both drugs are used to treat different phases of the illness. Yes, I think a drop is to be expected on Merck news too but factoring in the fact that we've survived the vaccine-drop and the imminent (and I use that word loosely now) news-rich period we're about to find ourselves in, I'd probably be forgiven for suggesting that it won't be as bad as it was.
Anyway, all of the above is just my humble opinion and nothing more than that (and certainly not financial advice). It's not my place to tell people not to worry as everyone's situation is uniquely their own. But for those of you who've made the decision to stay and strap in for the ride then we will weather the storm a little bit longer together as we set sail into the business end of H2. It'd be too late to alter course now matey! (I'm kidding, do whatever you want with your money).
I feel like we're merely weeks away and people are taking positions and I dare say it's time to sink or swim. Anyway, wishing you all a very happy Sunday.
Now... bring me that horizon.
So where does SNG001 come into all of this? Where is its place in the world? And how the blazes could its true benefits lie where we can harness its true power? Well there's still no evident progress a year on as far as I can see with therapeutics. A study has already showed Remdesivir doesn't actually improve survival. Imatinib has already failed to reach its primary objective. The current new drugs we have targeting the cytokine storm phase just aren't far enough yet in their studies. Ivermectin doesn't interest us yet and is still being looked at. And Dexamethasone is still centre stage which surely can't be feasible long-term as steroid treatments are not appropriate for everybody, let alone having to stop the Dexamethasone whenever a patient develops a raging pneumonia which happens very often. We've had a case during this wave where we had to stop the Dex when the patient developed a super-imposed pneumonia and then developed a fungal infection after that which ended up ultimately leaving large cavities in the lungs. How do you go about treating patients like this if you're constantly having to switch between treatments? It makes me realise how valuable a treatment like SNG001 could be if it's just constantly running in the background for example.
To the wobblers, I advise you to keep the broad spectrum anti-viral vision in mind and keep the faith along with it. A wise man once said that ambition without knowledge is like a boat on dry land. The science has been speaking for itself for a while now and the recent literature that's provided invaluable information about just how vital boosting the immune response in a person can be in improving a patient's clinical state instead of trying to lower the viral load, proves just how important of a role interferon can play in the near future. That piece of literature has propelled this company forward a few more steps and I feel as if we're almost ready for a paradigm shift in medical treatments of respiratory illnesses. Exciting times ahead for us all and I'm not worried in the slightest about where we fit in - in fact I'm only bouyed by our prospects (see what I did there?). To Gunto, I now speak directly to you. Many of us here are more than comfortable with what we're invested in and Molnupiravir was on our radar long before you came along. You've been called out on it already and we'll leave it there but just so you know if you're thinking about bringing any of it up again then please feel free as it's a free world, but you're wasting your time here on LSE.
(6/7)
The Americans are now dealing with the delta variant with states such as Florida setting all time records since the pandemic began, and the wave's only just starting over there. China and Myanmar are now about to follow suit. Some populations out in the far east are even having trouble with the fact that this virus exists and that its effects are real which could explain why the uptake of vaccinations there is so poor. With the majority of these populations not having grasped the importance of vaccination, I doubt they'll be able to grasp the importance of any other prophylactic treatments such as Merck's pills in time for this wave or the next. When I'm on the wards I'm constantly wondering where we can fit in and I've no doubt that Molnupiravir can be helpful in the future but I'm struggling to understand how and where just yet, because if people have milder symptoms I'm not sure how determined they're going to be to take a prophylactic pill and if they're more breathless requiring hospital assessment then I'm not sure how much priority a pill would be given over a nebuliser that could prove to be more effective if trial results prove that. I'm discharging patients daily with steroids and antibiotics after I've deemed them fit enough to go home and I see a massive role for our drug too. I stand by SNG001 being suited well for home use but after having worked on these patients through the entire pandemic I can see it being incredibly suited for hospital use. So taking all of this into account, there's a place for it to be not only alongside the best, but to actually be the best in this current crop of mediocre attempts at controlling a virus that's proven its ability to outsmart us on more than one occasion. The final couple of hurdles are about to be jumped in this drug's journey to approval and in my opinion it can't come quick enough. If there's any hint of good news, no matter how low or high the clinical improvement rates, it would make waves against the current group of drugs trying their best to be what we need them to be.
(5/7)
The demographic of patients is even stranger than the demographic we saw in the second wave. This batch of patients appear to be younger, with a lot of them being unvaccinated, some being vaccine-exempt, some having vaccine failure from immunosuppression, and some even being double-vaccinated. Some of the ones that are vaccinated have been observed to have some underlying health conditions but I feel that I need to flag up here that we've noticed some of these health conditions aren't even severe enough conditions that would explain the concomitant illness. This is a new snippet of information that's began to trickle through and is causing some concern. Elsewhere outside of ITU on the designated Covid wards and Covid Assessment wards, we're seeing the same demographic of unvaccinated and vaccinated patients, with some just as sick as patients were in the first and second waves. Poor oxygen saturations with static progress and decompensation to hypoxic brain injury, unremitting chest symptoms still very much prominent, and bloodwork derangement such blood gas patterns of high base excesses in patients that I've not seen since the second wave.
This third wave is sweeping the NHS like a hurricane and people are dying. It isn't discriminating and it's showing just how merciless it can be against the defenceless which is what we still are without effective anti-virals. It takes me back to the horrid days where things like having to wait for our teams to finish their CPRs on patients and then giving the ventilator to somebody else if that patient didn't make it was a regular occurrence on a daily basis. The total easing of restrictions that's occurred means that this time I assume cases will rise for longer with a staggered up and down phase and then a plateau phase which may be prolonged compared to the previous waves, leading to a longer wave overall with the easing of cases and deaths occurring later than initially expected. One of the main things I want to feed back to you all is that discussion I had with one of the senior medics who blatantly just said that we have the oxygen, the ventilators and the steroids but the one thing we don't have are anti-virals we can count on.
(4/7)
In ITU itself there are several trials running including RECOVERY, REMAP-CAP, and UK-ROX. Patients upon escalation to ITU are assessed using clinical markers and then shuttled into separate parts of the ITU where different trials are being held. For example some patients are deemed suitable to be tubed with trial drug or placebo, some are deemed fit enough to be treated with CPAP with supplementary oxygen, some are trialled with differing trial drugs that are ongoing and some are being trialled with combinations of trial drugs, etc. Immunomodulators such as the interleukin-6 inhibitors targeting the cytokine storm phase are being watched closely, as are agents like monoclonal antibodies, interleukin-1 inhibitors and anti-virals. Remdesivir was bumped a while ago and Ivermectin isn't even being used here and never was. Some of these trials offer fluidity in terms of the ineffective agents being bumped from the trial and replaced with ease for particular batches of patients. All agents and their responses in the patients are all being watched round the clock by research nurses who come and log the trial data on a very regular basis, most of them on an hourly basis. All of this while complications are constantly arising such as drops in blood pressure. Anyway, trust me when I say recruitment isn't the issue when it comes to a lack of news.
Blood-thinning medications are now being given more attention with more evidence having come through regarding Sticky Covid. With the increase in lung cytokines signalling the synthesis of hepatic clotting proteins during the illness, in addition to the length of immobilisation the patients go through during their hospital stays, as well as the fact that this virus can actually enter the walls of the vessels, the chances of the blood getting 'stickier' and forming thromboemboli in the lungs are increased. We're seeing clots happening in major vessels in the lungs of patients whose lungs are already crippled by inflammation but we're also seeing smaller clots in the smaller vessels like the subsegmental arteries. Lines being used to administer trial drugs are at risk of clots so therapeutics can't even be given without the real risk of the patient developing a clot and potentially a secondary complication such as ischaemia. We've had cases where this has already happened, hence the recent shift in focus to the importance of blood thinning medications in severely ill patients with Covid in addition to all other therapeutic attempts. The general consensus is that the less inflammation there is in the lung, the lesser the chances of developing these clots. And until we figure out how to control that inflammation, small doses of blood-thinning medication is therefore being given to a lot of our patients to counteract and prevent this. If we had a decent anti-viral then we'd have less of the inflammation that follows and so the rest of this wouldn't have to be given so much attention. Food for thought.
(3/7)
Over a year on, corticosteroid use still remains the cornerstone of treatment of Covid-19. Dexamethasone in my hospital is still the steroid of choice with the dose being tweaked based on clinical pictures on the ward, with combinations of other agents like Baricitinib or Tocilizumab being used. Remdesivir is no longer being used by us and hasn't been for a while. Other methods of treatment such as high-powered oxygen administration is currently being trialled, which is sort of a half way point between nasal cannulae and CPAPs, and seems to fare better than things like 15L of oxygen through a non-rebreath oxygen face mask and allows treatment to be given elsewhere rather than an ITU unit (I'm going to interrupt myself here and just say that there's a reason that one of the exclusion criteria of SG018 is patients who are on mechanical ventilation or have been admitted to intensive care, so I'm going to need you all to read between the lines here and have a think about what this could mean for where in a hospital our drug would be effective, especially if you consider the inclusion criteria being that they need to be requiring oxygen therapy via nasal prongs or a mask with an OSCI score of 4). Proning patients for several hours a day in ITU by designated proning teams is still being done with patients getting their endotracheal tubes suctioned regularly and nursing staff having to do things like provide oral hygiene care and hair detanglement because of how many times they're being flipped over. Yes the proning does help but goodness me does it make me wonder why we're no further forward this far on into the pandemic. The only real difference I've seen is with ward management in terms of managing sick patients on the wards wherever possible instead of almost guaranteed escalation of sick patients to surge ICU units and main ICU units.
Our ITU unit shut its doors to new admissions just over a week ago. The neighbouring ITUs in neighbouring hospitals then shut their doors to new admissions a few days ago. We're now using theatre rooms to contain the overflow of sick Covid patients and as a result operations are being cancelled once again. Partitions between ITU rooms that were separating non-Covid patients from Covid patients have come back down again which has been demoralising, and our hospitals are now at full capacity. Temporary wards next door as well as wards next door to our Respiratory units which have been empty since the first wave have now been re-opened for the first time in a long time. Staff morale has plummeted again and we've been running on skeleton staff for the past three or four weeks with fellow medics off with Covid or isolating. The dissemination of Covid patients throughout the entire hospital has already occurred and Pandora's box of lifting restrictions too early has been opened a couple of weeks ago. It's now a waiting game to see whether we can contain this or not. The next few weeks will be telling.
(2/7)