I agree that 100k treatments is an excellent output in SNG’s situation. My point was that, notwithstanding vaccines, it this level of output is likely to be outstripped by demand and that there would probably be scope for up-gearing in-year.
If I have one concern regarding the strategy laid out last night - and this is not a de-ramp, if anything the opposite - it is that 100k treatments in 2021 will be nowhere near meeting potential demand. But we have to be realistic about the pace of gearing up that the company can bear. If things go according to plan, results wise, I can see that figure being revised upwards when revenue starts pouring in. Hope so!
Otherwise, a very informative hour, particularly the q&a. I personally don’t expect the webinar to influence the sp very much as 90% of attendees were invested in SNG. Hole i am wrong.
Hospitals at breaking point. Still can’t get a measly 110 recruits randomised in the home treatment trial? WTF? Instead of spending all of our energies fishing victims out of the river, somebody needs to go upstream and stop them falling in!
It looks like the initial euphoria following the announcement of the first successful vaccine trial is beginning to wane. The German Turkish developer of the new vaccine was very clear on Andrew Marr this morning regarding the limitations of the vaccine both in terms of when it might become available to the general public and on its likely efficacy and duration limitations. “We could have a normal winter NEXT YEAR” An interviewee on CNN this afternoon was similarly blunt about the timelines applicable to the general public as regards access to a vaccine - “summer of next year”. And that is before we get into the vaccine denier brigade and their impact on the development of herd immunity - or not. I am sure that Synairgen management have factored all of this into their business planning. There is going to be a healthy market for effective COVID treatments for the foreseeable future.
Yes, great piece of support for the company, SNG001 and the upcoming Phase 3 trial. Shame it has been upstaged somewhat by the Yorkshire Ripper and the Barnard Castle day-tripper. Let’s hope for a better shake in the weekend papers.
Dumbpunter - I don’t know what your background is but it is certainly not in medical statistics. The meaning of “p=0.096” is that there is a 9.6 chance in a hundred that the effect observed could have arisen purely by chance - just under 1 in 10. The convention is to regard such a chance as “statistically significant” if it is less than 1 in 20. So, the researchers can’t claim statistical significance but there certainly is a strong trend towards significance, particularly in the context of the other observed differences between the study and comparison groups - all of which were in a favourable direction.
Not wise to show your ignorance in such a (deliberately?) unhelpful way.
“Interferon deficiency can lead to severe COVID ...”. Nature 2 November
https://www.nature.com/articles/d41586-020-03070-1
Apologies if already posted.
My own gut feeling - not backed up by any hard evidence - is that nobody is taking responsibility for patients with COVID before they become so ill that they need admission to hospital or, in the case of the elderly, they die pretty well untreated at home. This I believe is ghd elephant in the room and a pretty scandalous elephant it is. If SNG001 is to have a material impact on hospital admission, itu admissions and death rates, it will need to be used upstream of the onset of severe disease and something is going to have to change in primary care going forward, and urgently!
Patients recruited will start on treatment pretty well straight away as they will have COVID disease. So the limiting factor will be the speed of recruitment. As I understand it the hope is that enough patients will be recruited to reach target numbers around the end of the year and finish treatment some time in Jsnuary with results in February.
Bizarre! All of today’s trading took place in the dark in respect of those immense Thursday trades and how they reflected market sentiment. If I had taken fright and sold shares today feeling that the sp was heading south because of a lack of buying sentiment, i would be a little miffed right now.
Firstly, those here highlighting the difference between systemic (subcutaneous or intravenous) interferon and SNG001 are right on the money. Inhaled delivery means less drug, direct action where its needed and less side effects.
I do think, however, that the publicity around the WHO trial may have a short term dampening effect on the sp. if I was in this for a fast buck, I might be a little worried by the reports. News from Synairgen in due course should sort that, though.
My understanding of the status of the ongoing SNG001 trial is:
The ongoing study started out in March as a trial comprising 2 components: a hospital arm and a home trial arm. The former made more rapid progress and closed in early July with the announcement of interim findings shortly in late July. The protocol was amended in August to the effect that, on completion of the second of the 2 initial arms of the study, now designated “pilot studies”, the trial would roll forward into a “pivotal” stage with a further 200-600 subjects enrolled (total with the original 210 now 400-800). The actual numbers required for the pivotal phase would be determined by the outcome of the 2 pilots. The pivotal phase would have the equivalent status of a Phase 3 study in regulatory terms.
We can only speculate as to where we are on the journey from the announcement of the revised trial protocol to final completion of the trial. My guess is that we are now into the pivotal phase but I have no idea how far into that we are and what numbers will have been determined based on the outcome of the initial home trial numbers. The listed date for the completion of the trial is 1 February 2021 but that is presumably based on a need for 800 subjects and limited availability of cases - so a worst case scenario. There must be substantial pressure to crack on in the circumstances of the current wave of illness. Let’s hope that we are close to the finishing line but recognise that we could have a while yet to wait. I also believe that peer review is a red herring - I am increasingly of the view that there is no intention to publish what is now regarded as one of two pilot studies and that we will not see a scientific publication until the trial, as now defined, has been completed. This is almost entirely irrelevant in regulatory and commercial terms.
Yes, toxic and really breathless. What a stupid man. He is taking the ultimate gamble. Whereas Walter Reed is a proper tertiary hospital, staffed by real specialists, the so-called “medical centre” in the White House looks to be not much more than a sick bay, albeit a rather plush one, staffed by an osteopath (Dr Conley).
God help him!
WedME, thank you for this synthesis. Very helpful even for those here who understand a bit of the science to have the strands brought together as you have done.
A question, prompted by another post, “competition dropping like flies”: Gilead’s trial of subcutaneous Rebif (INF Beta 1a) has been paused, at least for severely ill patients because of a higher incidence of adverse effects in the study arm. We know that nebulised SNG001 has a good safety profile. What is your take on this information in terms of implications for us?
The Daily Telegraph has an article today regarding “rationing” of Remdesivir. I posted the following comment there:
What has happened to the new Southampton interferon drug, SNG001, that was credited with reducing chances of serious illness ensuing in cases of COVID by 80% some 2 months ago? Since then - radio silence.
Meantime, mounting evidence from across the world seems to show conclusively that intrinsic interferon deficiency, either because of gender, age or other patient characteristics or as a result suppression by the COVID infection, is closely linked to the more severe, life threatening, form of the disease.
Why is there so little public and clinical focus on interferon treatment generally and the Southampton treatment in particular?