Ben Richardson, CEO at SulNOx, confident they can cost-effectively decarbonise commercial shipping. Watch the video here.
Just your resident seafarer here to steady the ship amongst these choppy waters we find ourselves in with regards to a lack of trial updates, and to address a certified Molnupiravir-spinning chap while I'm here. I'm here to provide an update on what's going on behind hospital doors, and before anyone asks I can't give absolute specifics on trials and inner workings as usual but I'll do my best with the rest of it, as I'm sure many of you would do the same for me. I'll then explain why I think SNG001's place in the world will not be affected by these up and coming drugs. I'll clarify now that SNG001 isn't being used at my hospital.
So we're in the middle of a third wave as predicted and despite what you're all being told, our admission numbers are rising exponentially. When the first wave started tearing through Europe, the Italians, the French and rest of the Europeans were subjected to the onslaught before the rest of us and were caught off guard by the novel virus. Through their efforts they were able to feed the rest of us here in the UK tips on how to go about managing the disease. One of the things the Europeans advised us to do was to intubate patients as soon as possible and to avoid steroids, however we now know that tubing patients straight away isn't necessarily the best way to go with a recent study showing that one of the first batches of tubed patients during the first wave yielded no survivors. Before long it was our turn to deal with the virus and we were at the mercy of a disease that despite our best efforts and even with following the advice we were receiving from across the waters, nothing could stop the horror that was unleashed upon us. However through trial, error, and a dash of tenacity, we began to see some small progress and a pattern emerged - using steroids wasn't actually the worst idea in the world and tubing patients only when needed instead of as early as possible seemed to slow the number of deaths. Numbers started to improve and we began to stem the tide and just like that, steroids took centre stage. Cue the fanfares and Dexamethasone gets approved for use.
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I don't think they're planning anything at this stage doc, just foreshadowing and putting things in place for when we're done with the pandemic. That's what I reckon anyway.
For what it's worth I don't plan on sticking around for any more trials so the sooner they can wrap up SG018 and get it out there saving lives by way of approvals, licenses and sales, the better.
I recall a certain comment about a possible ITU trial when all's said and done with SG018.
Restarting COPD trials in the background once our product's officially licensed for Covid-19 treatment would allow for further intel and possible further licenses down the line. Or starting brand new trials like the ITU trial that was mentioned, not to mention the other range of viruses that our drug needs to be tested against (such as RSV) which need to be studied in trial format before being licensed.
So surely by those definitions it's not possible to have both the primary completion date and the study completion date on the same date then?
I say that purely on the basis that the primary outcomes for SG018 are one thing but the secondary outcomes require follow-ups on all of those follow-up points and dates which would take the longest. So if we go by the primary completion date then surely that would mean we'd be eligible for the readout of the primary endpoint data only. But if we go by the study completion date we'd be eligible for the entire study data like what happened with SG016 after the full study was released after the July readout. Not sure if I'm interpreting that correctly at all but it's confusing how they're not differentiating between the two on the trial website.
Cheers Matt.
Another bunch of sites to fill up the 610. I agree I think they'll have been up and running for a while. I'm still not sure what primary completion date means either way it can't be too long with even more sites added now.
Mabs are proving to be difficult to progress with the concerns regarding monotherapy and whatnot. As far as orals go their trials aren't moving quick enough. Which makes me wonder just how much of an impact this company is going to make if our drug gets announced before any of them get licensed for use. Mindboggling how much this could potentially rocket and we're so close.
Matt that's correct, that's my understanding of it.
Whether you're in the first cohort of patients who are severely breathless at home, who pick up the phone, get directed to hospital by emergency services and then get assessed on the same day in an ambulatory unit for example, you can still get discharged home to complete outpatient treatment and not be hospitalised. These people get assessed by us and discharged on the same day with courses of antibiotics and oral steroids all the time so there's no reason they couldn't be sent home with a course of SNG001. These people would therefore still fall into that 10% category that RM alluded to.
If you're in the second cohort of patients who end up being admitted due to an increased oxygen requirement then chances are you'd be kept on the ward until you're stable enough to be sent home to complete the treatment anyway.
Doc, the consensus at the time that she was first dosed was that her and other patients like her would be treated in hospital first, shown how to use the drug at home, and then sent home to complete the course of treatment.
If I remember correctly she was shown how to use it by the research nurses and the staff nurses on the ward which would imply that she was indeed sent home to finish the course. So yep, I'm definitely not worried about our applications.
Hi Candid. This is a good point to raise and I'll answer it from the clinical point of view.
When we assess these patients over the phone or in person and they're suffering from breathlessness, then you're right. We would have a tendency to send them in rather than keep a breathless patient in the home setting. That's if we saw reason to and there were other confounding factors such as possible infective markers, systemic signs of deterioration, and the general feel of a patient that's going to decline rather than improve if left alone which is a skill we learn to hone over the years. Keep in mind though that not everyone experiencing breathlessness at home is going to be sent to hospital. Think about the asthmatics and COPD sufferers who suffer from breathlessness all the time - they live with the symptom on a daily basis and know what a deterioration feels like and aren't going to be rushing to hospital as soon as they feel out of breath. The average asthmatic would probably reach for their inhaler first rather than the phone - if they weren't having a crisis that is.
Let's say that the patient does end up in hospital. I'd say that once we've assessed them, seen that they're hemodynamically stable, don't have infective signs such as lung sounds or infection markers in the bloods, and lack other hallmarks of severe disease such as cardiac abnormalities or pulmonary emboli for instance, then there's scope to send these patients back home with a course of SNG001 and a sats probe and ask them to monitor their sats on a daily basis. We send patients home with antibiotics all the time after we've assessed them and we make sure they continue to monitor at home while taking the treatment.
Of course there's still work to do to identifying the specific 10% cohort that this drug may be aimed at in the home setting, but there are ways.
You've echoed my thoughts exactly Doc. The speed at which things will move after that long awaited RNS will be something to behold if everything goes to plan.
People lamenting the slow progress aren't understanding how much of a mistake it would have been to negotiate after P2. Not having done the heavy lifting we're doing now will have given us no leverage and nothing substantial by way of an accomplished and approved product to offer a Pharma Co apart from a menial sucess based on 50 patients.
Gathering data on several hundred patients across three further trials after P2, a peer-reviewed publication, in vitro studies proving success against variants, and progression in separate countries with possible EUAs or pre-orders has catapulted this into a separate price bracket altogether should stars continue to align. And this is all being done without the company uttering a single word through an RNS. So I'm happy with the radio silence to continue because with every day that we don't hear anything is another day that we haven't been informed that plans towards the end goal have changed.
Yep, quite amazing how they've all disappeared Matml. Just goes to show that when things get rough here there's a scheming system in place that allows certain individuals to pounce on any negativity to sway the minds of the vulnerable. I couldn't be prouder of those of us that can see right through them and stand our ground.
Appointment of a CCO makes the company's and its CEO's intentions clearer in my opinion. I've been looking into the precise responsibilities of CCOs and what other biotech CCOs have been responsible for and it seems rather telling. Establishing the correct market for product sales, creating commercial sales teams, supporting the business as well as developing profit for the company, developing strategies to reach company goals and milestones, and of course managing product sales. Just to name a few.
I wonder if Ghia's licensing hunch was more than just a hunch. Why would a CCO with these responsibilities be hired if we were looking to get taken over and relinquish control anyway?
Interesting theory TLW, one I'd never even pondered. With the annual results coming up and us being in the middle of Activ-2 and a global P3 it seems a bit strange to leave everything half way through, but there may well be many goings-on behind the scenes particularly with the new dataset we've just received. I think we're still a couple of months away from having these talks so I'd be surprised if those talks were happening at this stage and not in the summer.
Having said that though, the hint that manufacturing was starting in the summer, the company vacancies spotted a while ago, the hiring of these top dogs, all seem to be pointing towards something monumental happening in the horizon and those things can't be planned and executed all at once, meaning they clearly know a big change at the company is imminent and are preparing for it, or they're putting the wheels in motion for when that time comes. With us in the middle of two trials at the moment, I might go with the latter.
Also MrCosts, I did note your moaning this week but it's been understandable. Good to have you back on board.
Great idea to start a new thread based on last night's discussion regarding licensing vs TOs and an excellent original post. The thread's gone on a bit of a tangent here with tax talk though so I'll bring it back a little.
As far as TOs go, I have a question and it relates to what Matt posted earlier in this thread. I've never been invested in a company that's gone on to a licensing/TOs so I'm not sure how it works or what happens on the day of the TO. But if a TO were to happen and they offered a price one morning and I accepted, then I'm assuming I'd sell based on the new price and I've made some money (no less than a ten-bag myself as well I hope). But if I didn't accept the TO price offer then what would happen, would the company SP then shoot up to the price that was offered to all investors and we continue to hold but this time from the new price?
And also, if that's the case then why would anyone accept the price that was offered in the first place?
Interesting replies. The licensing route would surely 'maximise shareholder value' and would earn this product the respect and fair value it deserves after all the heavy lifting we will have done. If I didn't mind waiting it out for an unknown length of time then I'd go this route.
But like it's been mentioned in a few of those replies the clean break sounds far more appealing, and Matt your point about not knowing when to part with your shares and possibly wanting the decision taken out of your hands is one I'm leaning more towards.
As you say Ghia, either way I'm sure we get rewarded but if I were to have a preference I'd go with the takeover purely because I'd have no idea how long a waiting game I'd have to play. Fully understand the marathon strategy though but I'm not sure if it's for me.
Cheers Ghia.
That certainly does make sense, especially from the global approach that's clearly evident here. Don't worry about the hunch - it seems like a well placed one. I'm sure we'll get further clues in due course as to which route we're going.
So while we're on the topic, I know this is a very naive question to be asking this late on but would people here prefer the licensing route or the takeover route? And why?