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The answer is simple. Boris Johnson in his rambled speech the other evening said that we have treatments developed in the Uk that can be used for people suffering from coronavirus.
It's highly likely our treatment Sgn001 is top of the list unless I am missing something.
Good weekend all.
That is one of the reasons why it should have never gotten (or maintained) the the EUA status.
It is impossible for me to explain on this platform why "21% reduction in hospital stay" is complete nonsense (in terms of efficacy and in terms of whether we should even belive that with current data) when taking into account the full profile of this drug. That is the problem. People should trust health authorities, and that is why them still insisting that remdesivir is a solution or even helpful to anything is unethical in my view.
You have logged in with one of your other accounts Macosta. Silly goose.
Jest reading through the Preparing for winter report. This may have been touched on before but bearing in mind this was published prior to July 20th results the following statement regarding treatments some of the comments now appear highly applicable to the Synairgen situation.
"A number of other trials are in progress, and only when these are reported will it be known what the efficacy and thus the demand will be and in what stage of disease the medicines may be best used.309 The long-term control of COVID-19 will require a pipeline of promising therapies."
and then....." The challenges for treatment and/or prevention of COVID-19 with respect to medicines will depend on the timely reporting of trials, licencing, evaluation and commissioning of medicines with accelerated access schemes, as well as mechanisms to deploy these nationally at pace. Part of this is in place with the Research to Access Pathway to Investigational Drugs – COVID-19 (RAPID-C19) led by the National Institute for Health Research (NIHR), NICE, MHRA, and NHS England; however, the manufacture and supply of drugs needs to be modelled in a global context, and with consideration of winter surges. In addition, a bottom up approach to operationalise commissioning decisions at pace is required, which will be more urgent in winter months with added pressures.
Early signals should accelerate negotiations with pharmaceutical companies, including generic manufacturers. Schemes, such as the six-week rolling stock (in place for no-deal Brexit) and others, should be considered to help maintain supplies while avoiding stockpiling more than is required. This may be particularly applicable to the drugs currently in trial.
Horizon scanning by bodies (e.g. RAPID-C19) can pick up on early signals to ensure a winter supply chain is in place given any modelling as described above. This needs to occur in tandem with early liaison with bodies that can facilitate expert review and ensure the operationalisation of commissioning policies (e.g. formulary committees)"
Report can be found here:
I think we aren't too far away from big news!
Qd, I think Synairgen have are very well connected into central government for this not to be a worry.
Prof. Stephen Holgate has had plenty of contact with Prof. Chris Whitty over the years while as Chair of the CFS/ME research collaborative. This can been found through searching their board meeting minutes.
HE also chaired the expert advisory group ‘policy report’ on ‘Preparing for challenging winter 2020/21 for the academy of medical sciences.
IMHO I think the Patient groups, Political (all sides), Medical and Scientific community would come out in the droves if they thought an excellent treatment such as SNG001 was being held back or buried. My guess/gut feel is that its an NDA and Due Process to verify the claims are the root. Then concomitantly (I hope) they are ramping (positive use ;)) up from Trials, Regs , QA, to Manufacture and distribution etc etc, which all take a bit of time.
I trust that the leading runner, with SNG001 on the vest, is now turning the corner in to the final straight, no looking back, the finishing line is in sight.
Just to repeat, imho remdesivir should not be seen as a competitor to SNG001.
Remdesivir is intended for use in hospitalised patients.
SNG001 is intended to help stop early symptom Covid sufferers from ever needing to go to hospital.
> I was under the impression that COPD trials have already proven safety... ?
We don't know if the numbers were sufficient to prove anything. We do know they are still running trials, one arm at least(home).
>>Wrong. Remdesivir (an experimental antiviral) has never got anything more than a temporary EUA (based on hype)
OK, does not look like its being used in the UK in any case. Biut, the lead scientist in US is actively promoting it in the government video, states three double blind trials prove it reduces hospital stay by 21%
PhilGekko.... I'm with you on the conspiracy of pushing vaccines over treatments.... to begin with I thought it was just because they needed to achieve public trust so people took the vaccine ... but now I'm beginning to wonder how many 'helpful government advisors' have options to buy shares at a reduced rate in these vaccine companies if they should be successful..... If we think this kind of fraud happens only in countries like Africa, I think we are being naive.
How do we get the message to the press that SNG and interferons are better than a Vaccine right now. I know which one I'd rather take, so I can't be alone in this.
Your link goes to the US National Library of Medicine, big form I find hard to be confident I have understood correctly. The meat of it seems to me to be under Study Design:
"Randomised double-blind placebo-controlled
Pilot phase - 100 patients randomised in the hospital setting, 120 patients randomised in the home setting.
Pivotal phase - estimated at an additional 100 to 300 patients per arm, but the actual number will be determined after the data review at the end of the Pilot phase"
Clearly the pilot phase is what we got the results of in July. We have had no details at all about getting on with the Pivotal phase. And it has "No results posted" on the results tab, which is disappointing, given that the Pilot phase is very relevant and provided statistically significant results for clinical benefit, even it it is actually designed I think for safety, hence the small-ish number of patients - making clinical benefit very hard to establish at that stage. [You need to have a humdinger of a treatment to statistically establish clinical benefit with a small number - which Synairgen has done. We do have a humdinger.]
That clarifies things a little for me: but also concerns me. Again: what is going on? People are dieing - worldwide. One hears government has given so many contracts on tests etc to unproven obscure groups: does SNG just not have the right back-slapping ministerial mates??
@ Tonlin... completely agree with you. I am heavily invested as I believe in the science behind SNG001, but I am turning into a conspiracy theorist these days. Imagine people passing away becausebof some red tape or some interest groups pushing their agendas behind the scenes. Why is there no more spotlight on SNG? I want to be wrong (and really hope I am) but it doesn't feel right unfortunately. Even The Times and Bloomberg (!?!?) are not including SNG on the list of potrntial treatments, barely managed to get onto Guardian's list. What could ve the reason?
@dumbpunter.... good morning! I was under the impression that COPD trials have already proven safety... ?
Wrong. Remdesivir (an experimental antiviral) has never got anything more than a temporary EUA (based on hype) for any disease because it has never produced good enough results, including never demonstrating reduction of viral load in humans with any virus, which is what you'd expect an antiviral would do.
QD22 I believe there are ongoing trials in hospital.
https://clinicaltrials.gov/ct2/show/record/NCT04385095?term=interferon&cond=covid-19&draw=2&view=record had an additional hospital pivotal arm aded to the trial on 27th August.
Sir John Bell on 22nd Sept in an interview advised Inhaled Interferon Beta was under review in the UK wide Recovery trials.
There hasn't been anything offical from Synairgen but theres enough evidence from strong sources showing more patients are being recruited in hospital.
That's what I suggested to my minister MP 2 months ago. No reply of course.
@Mike29 & Scinv - great to know we're all on the same track! Great minds, and all that... Crossed posts, that't the trouble with crafting a long post.
Qd22, agree. That is what I am getting at in my post below. The only test I am aware of that is still officially going on is the home trial. Surely they won’t be asked to start a test now more than 2 months on from the initial results. That would take months and end up missing most of the upcoming winter. More likely imo that emergency use will be issued in conjunction with a side by side test at the same time.
People keep saying that it needs further tests, but
1. The July results, though on a smallish number of patients, were so good that they were statistically significant for benefit. Thus we KNOW it saves lives, which was frankly very very very likely before those test results - the virus had to be a whole new departure for it not to work.
2. We do know now it is safe, not only from the Covid trials but also the COPD trials. Further tests are for efficacy.
3. There is no word of further tests happening???? The last I think we have from the company is what I highlighted yesterday:
"Synairgen is in discussions with a number of regulatory agencies worldwide to establish the regulatory route to the approval of SNG001 as a treatment for COVID-19. 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." That's not tests it's just talks.
4. Do we have the results of the home trials yet? As far as I know not, the July results were for "hospitalised patients".
So really, what on earth is happening? I keep writing to my MP, a minister I am frankly ashamed of. I suggest everyone does similar. Please, please, please. If we have to moan, let's moan in the right place!
Tonlin, I agree it is bewildering that this treatment option is not being bought up more widely in parliament or mainstream news. I know if any of my family contract Covid over the coming months I would want this treatment available to them.
The interim results are due before Thursday so not long to wait for some news. I think much will be revealed about progression of the drug to market in them.
Dumbpunter, take your point re trials etc. So apart from the unfinished home trial of a target of 120 patients are we definitely undergoing any more trials today. If we are has that been notified to the market. I am confused as to what we are officially trialing at the moment other than the home trial, thanks.
Remdesivir was already approved for other diseases so its safe and side effects were well understood. In any case its is used very little as its apparent its difficult to use and not effective especially at the price.
Its an unavoidable fact that SNG needed to be tested on a lot more patients and only then can it be approved, if safe. Who can and a cannot be treated and when has to be confirmed. If home treatment is approved, then that would abe a game changer.
Once again, we have to be patient. It has to be tested and that takes time.
Zwart - Remdesivir was approved two days after clinical trials ended without any safety data. I think some of the frustration stems from doing a comparison between this, the focus (and money spent on vaccines by HMG) without any guarantee this is going to work and watching the number of deaths creep up on a day by day basis.
SNG did a gold standard Phase II trial and the data suggests that a significant number of those recent fatalities could have been avoided.
I trust RM knows better than any of us what he is doing though. I think we will hear something next week.
People need to understand that to find a thousand suitable people of different ages, ethnicities, at different stages of infection then monitor them throughout their recovery then assemble, review and compare results against placebo....then formalize and prepare a report for approval TAKES A LONG FKN TIME .....be patient .....It will come and it will be big
After a bit of thought I find I am beginning to disagree with myself. I have rambled on about getting everything in place before an announcement is made, Things like supplies, distribution etc. However, in the meantime people are dying. If (God forbid) one of my family came down with covid today, would I be happy to wait for all the ducks to be in place before we got treatment? Of course I wouldn't. If there is a potential life saving therapy out there I would want it now. Maybe all of the trial evidence gathered so far and the huge amount of anecdotal evidence showing the safety and efficacy of SNG001 really isn't enough. I have to admit, something doesn't sit right with me about all of this. I hope I am wrong. I have read every post (including all of the C**p) and can see that there are some very bright well informed posters who are also confused and perhaps uneasy. I'm not selling until 'the end' but I don't like the idea that agencies, whether it's gov't, regulators or whoever appear to be dragging their feet whilst loved ones are beginning to die. I hope something breaks soon for those who have been positively diagnosed and for those yet to be positively diagnosed.