Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
Fruitsnveg - speaking of mince pie. This weekend I tried a lethal combo, but so damn good! I had Waitrose’s brandy flavoured thick cream, it’s well flavoured, with mince pie. I wasn’t shy with the cream :-)
Do the smarties boxes still say ‘wotalotigot’?
Alphageddon - your question is beyond the limits of my knowledge.
Position filled.
Senior Clinical Research Associate (full-time, remote working)
An opportunity has arisen within the company for a permanent, experienced Senior Clinical Research Associate, supporting the Head of Clinical Operations and Project Managers, in carrying out and completing tasks associated with Synairgen’s clinical trials.
The only explanation I can think of as to why they only mention the US is because it’s the most lucrative market from a size and price point of view. So instead of listing other or all jurisdictions you intend to apply for an EUA you keep it succinct and focus on the most lucrative. They most certainly would be applying for EUAs in the UK, EU and any other country where possible.
Alphageddon - you seem to suggest SG108 was a UK trial only with your ‘completion by summer comment’. Shall I state that about 100 patients were recruited in the UK before any of the other countries contributed to recruitment. The trial took longer than anticipated due to the tardiness of other countries. Of course more could’ve been done, but let’s acknowledge the valuable assistance received.
Further, if Synairgen do not have the bandwidth to enter into negotiations with the UK Government then surely it can’t do so with the US or any other Government for that matter. Your comment does not make sense. RM stated long ago that they do not require the assistance of a partner during the initial stages as they’d be dealing with Governments directly.
Patagucci - I recommend you do some further research. Synairgen have received significant support from the UK Health Authorities with regard to SG016 and SG018, without which we would not have been where we are today.
The language has indeed changed. It’s worth bearing in mind that NHS England have fewer, by a few thousand, beds available compared to this time last year due to an increase in non-covid hospitalisations. That’s while covid hospitalisations are half what it was 12 months ago.
The problem right now is that even if SNG001 is given an EUA for hospitalised patients it will not prevent hospitals being overwhelmed which could lead to further restrictions and even potential future lockdowns. Assuming omicorn is as bad as feared. An EUA in the outpatient setting is therefore critical. It's a real pity that ACTIV-2 came to a standstill.
Thanks for that!
At least the trial will run when the omicron wave ‘peaks’. Well hopefully. A silver lining no doubt.
Does anyone from the Reddit group have insight as to what the latest is on ACTIV-2?
Elsol - you never really know with Synairgen meaning how they will go about things. And I mean this in a good way.
I believe there are more pressure now than ever before to get results out there as quickly as possible. In a way they have a duty to. I would not be surprised if results are announced later this month. Applications for emergency use approval will of course take longer due to the application and approval processes that need following.
I suspect the MHRA will be the first regulator to provide temporary approval based on their record so far. Followed by the FDA and then the EU. These approvals won’t come in 2021.
Published today https://www.nature.com/articles/s41598-021-03044-x
‘The mechanisms explaining excess morbidity and mortality in respiratory infections among males are poorly understood. Innate immune responses are critical in protection against respiratory virus infections. We hypothesised that innate immune responses to respiratory viruses may be deficient in males.
Our data support a preventive strategy, particularly among males, which involves targeting the innate immune system with ‘immune training’ agents to boost resistance to primary infection and enhance the capacity to control the intensity of airways’ inflammatory responses(60). Our data also suggest that therapeutic use IFNs, or of agents that boost innate IFN induction by virus infections, may be efficacious in treatment. This is supported by evidence from randomised controlled trials which have reported benefits of inhaled nebulised IFN-ß as a treatment of virus-induced worsening of asthma in difficult-to-treat asthma(61), and of patients admitted to hospital with severe COVID-19(62). ‘
Man flu exists :-)
‘Our findings have important implications for another hotly debated topic, namely whether “man flu” actually exists or not (66,67). Here we provide a biological basis to explain why males would be expected to experience more severe disease than females when infected by respiratory viruses.’
*14 day treatment period
The RNS released on 11 Nov 2021 used the following language '... has achieved its recruitment target of 610 randomised patients ...'.
It did NOT state 'last patient dosed' therefore the last patient only just started his/her 14 treatment period.
The 35 day period commenced on 10 Nov 2021, maybe a day or two earlier.
Kevinl1977 - I’m not on Reddit. You may have misinterpreted Joey’s post about Prof Fish being a poster on there, instead it’s one of the Reddit members who’s in communication with her. Joey’s post sums it all up - nothing more I can add.
For me personally I ignored that article, not because I’m turning a blind eye against some concerns, but more because I don’t find it well written or argued.
‘The Omicron variant of the virus that causes COVID-19 likely acquired at least one of its mutations by picking up a snippet of genetic material from another virus - possibly one that causes the common cold - present in the same infected cells, according to researchers.‘
https://www.reuters.com/business/healthcare-pharmaceuticals/omicron-variant-may-have-picked-up-piece-common-cold-virus-2021-12-03/
Synairgen have not yet released the results from the in vitro experiments concerning the Delta variant. Assuming they have requested such experiments, although it is the understanding they have.
Thanks
Matml74 - hypothetical question for you if you don’t mind. My response to Blue83 was (probably) a bit far fetched.
Let’s assume Regeneron’s mAbs are ineffective against omicron and there’s no alternative except a placebo, but you don’t want to go down that route. In the world of trials would it be conceivable to continue the trial without practically having an active comparator, for the reasons mentioned, alongside the trial drug, but you compare the trial drug’s results against the active comparator’s results achieved against a previous variant? Also assume the inclusion & exclusion criteria are the same.
I’m not suggesting this might happen or advocate this. Purely just a question out of curiosity of what could be possible.
Blue83 - Matml74 is more qualified to answer your question, although I’ll share my view. I did think about this a bit further since my post and I’d guess Regeneron’s results can still be used as a benchmark even though it was against a different variant. Any new drug to be trialled would need to perform equally or better against the new variant than what Regeneron achieved against a previous variant.
For SAB it could mean that their MAbs treatment potentially gets removed from phase III.