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The trial medication will be administered as an aerosol via a handheld nebuliser. The trial nurse will train you on how to take the trial medication via video call. You will take a dose of trial medication once a day for 14 days
Miggy,
Sooner rather than later would be fantastic from a clinical point of view. :-)
Bojo- that may be your idea of reality it certainly isn’t mine or others on here. There is a pressing need for this drug now. No other drugs thus far help much unless you are on deaths door. There are grounds for granting quicker market access due to the necessity of saving lives along the lines of ‘right to try’ access as they have in the states. Also this hasn’t been tested on a hundred people. It’s been tested on patients in Asthma, COPD and the hospitalised Covid trial. Enough numbers to match other drugs FDA expedited approvals in the past. I hope people keep the faith, we have good things coming soon.:)
I accept your point Sparkle. Preparedness is certainly a good sign :-)
Please forgive this pedantry but it is important: “Inhaler” and “nebuliser” are not synonyms. SNG001 is administered by a nebuliser, not by an inhaler. An inhaler, as typically used by people with asthma, is a pressurised apparatus that needs to be “fired” by the user in synchrony with inspiration (breathing in). A nebuliser produces a mist that is breathed in somewhat like the way one might use a vaping pipe if one was stupid enough to indulge in the habit. Nebulised medicines can be administered to sedated or ventilated patients with a bit of ingenuity in a way that a drug in an inhaler can’t. So, let’s keep to the term “nebuliser” when talking about SNG001.
Not so sure bojo... funny times... syn said they had scaled up for this autumn so not sure theyd be doing that without a nod to at least a very large scale test/trial/roll out.
I am sorry to say Larry that little SNG must push this through phase 3 trials. Not only that but the numbers of people taking part need to be higher than just a hundred or so. The fate of this vital therapeutic lays in the hands of the BOD and Richard Marsden and not the Government. That is just reality I am afraid.
I feel sure that RM has started the wheels turning of the phase 3 (pivotal trial) and that he will endeavour to find as many participants as possible. At the same time he will no doubt be talking to partners about possible deals. Without a helping hand this looks likely to drift on beyond May 2021 as that is when the trial ends.
This is becoming a mid to long term hold for me and I think most of the rainbow chasers will be long gone by then. This drug will work, it will make it to market and will be monetised. Holders just need to conform their thinking to the reality of what is actually happening and more importantly the amount of time that will take. Only then can one rest easy and feel relaxed with the investment.
Me, I wish SNG could get approval tomorrow so that people could receive the drug straight away. It would no doubt save many lives. The reality is it will take a long time. I will hold for as long as it takes.
@hayashi - the nebuliser used in initial testing is made by Philips.
Some have suggested we may work with Vectura in future.
I would suggest that the company probably feels an overwhelming sense of urgency as well as deep compassion for the victims.
I think they've scalled up but nobody has any urgency about getting it into patients and keeping people alive.
Scinv - your efforts are valued and you're not allowed to give up :)
We'll get there. IMHO funding is not an issue unless there is some unforeseen disaster - and remember we're just putting a missing protein back in, it's nothing very fancy. We have the theory, everything we've learned along the way supports it, we have good data and we're getting more.
Love this one: https://www.youtube.com/watch?v=CEn16_T-FGU
In RM’s position I’d spend as little as possible to ensure that I’m in a position to ramp up production with as little lead time as possible. That would mean paying for long lead time items well ahead as he suggests, and identifying the point at which risks are minimised to make a decision to flick the switch on full scale production. That might include some early completion of finished product but might not. This would all be part of ensuring that the company’s resources are used as efficiently as possible.
Not having quantities is not an issue at all. There are so many CMOs (contract manufacturing org.) that would jump on this immediately, SNG is not meant to manifacture anyways. Once there is any kind of an approval in place everything else will go very quickly, money is no longer an issue as SNG would be sitting ona blockbuster. But we need to get there... wondering why emergency approval is taking this long considering that COPD trials are showing that it is safe???
You've actually inferred on both counts; that there are piece(s) missing from the supply chain and that they won't have meaningful quanitites in place should they get approval.
Not having meaningful quantities ready to go is a risk that RM has openly spoken of over the course of the last 6 months. They won't be caught with their pants down on that one.
'What matters is as it is now there is no meaningful quantity of product manufactured for use outside trials.' That statement is unsubstantiated Scinv.
From the latest RNS, "We are also working closely with the Company's manufacturing partners on scale-up activity and will provide a further update on these matters in due course"
He has made it clear in a number of interviews over several months that they don't want to be in a position where they get approvals and can't help people.
Just re-watched it; He is specifically talking about the previous fundraise in March and says they used some of it to focus on some of the cheaper supply chain items that have much longer lead times - so that if they get approvals they have the drug on the shelf.
He does say that they'll need more funding (understandable because demand will likely be huge) however he doesn't say they need funding to have meaningful quantities. In fact, he's went on record several times in previous interviews to say they were working towards having 'meaningful quantities' (his words) in place for winter.
£14m raised. Contributing to less expensive items and those with longest lead times. So sensible but not really specific enough to understand what isn’t being produced, how much it would cost, whether they have much in the way of finished product.
Do we know who makes the nebuliser?
Scinv, I'm not sure what you mean about only ramping production for part of the drug?
RM has been very clear in several interviews that they've been working toward being able to supply millions of doses by winter. Thats everything thats needed to treat people should the drug get approved.
You make some good points Scinv. I wonder how quickly production of the key components can be ramped up, any guesses?
@Larryh... like you, I despair when I think about what BoJo should be doing, but isn't, and things that he is doing that are very questionable (mainly wasting OUR money but other things as well). However, has anyone ever thought that the Covid he got might have damaged some of his brain cells? GLA Synners.
I listened to the BBC 5 Live Rhod Sharp show this evening Friday night 2200 - 0100 Saturday. His phone-in callers were talking about the effects covid had on them and their inability to get any treatment help. When they turned up at the hospital they were told to go home if their symptoms did not appear serious . Those who were admitted seemed not too bad at first but their condition soon deteriorated rapidly. The hospital doctor being penetratingly interviewed by Rhod was trying to be conservative in his replies, but Rhod got it out of him that those admitted with acute symptoms could not be helped and would deteriorate rapidly and within 4 hours could be dead. I kept asking myself during the interview why the SNG inhaler was not given to those people with early symptoms. Surely this would have staved off things deteriorating!!! The inhaler has been shown to be very effective in the phase 2 trial. We are in a very serious emergency situation and everything needs to be given, even if the phase 3 trial etc is not completed yet. I despair at Johnson.