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200 patients in UK over 20 sites
300 more in EU across potentially 130 sites
400 for rest of world - i would assume very high proportion in USA.

It may say 26 countries but vast majority will be done in uk/france/germany/spain/italy/usa I would suspect.

Richard has said the reason for having many countries is you need to chase covid round the world to get the patients on your trial. If you just do in UK then if the 2nd wave and hospitalisations drop significantly you won't have anyone on your trial. There have been various reports of drug makers being unable to do trials due to no patient availability due to the competition. So its common sense.

The other reason as alluded to is each country has their own EUA process. So with clinigen deal we have an increased chance of 1/26 countries giving an EUA.

There is good reason we raised so much cash to pay a 3rd party handsomely to take care of these international trials.

F.1.3 Elderly (>=65 years) Yes
F.1.3.1 Number of subjects for this age range: 450

50% of patients over 65 in the trial thats a very good idea.

The obvious competitor to SNG001 in the home setting for at risk people is the mAbs treatments.. Recently Eli Lilly got EUA for home setting use but interestingly no approval in the hospital settings. Problem with mAbs is the method of delivery is both expensive and difficult as they need an infusion. Maybe it has decent efficacy for prevention at early stage Covid-19 but not its not realsitically suitable for the home setting.

Other companies are working on different delivery systems for mAbs treatments. Injection and inhaled methods are still in P2/P3 stage but these will likely become the front runners purely due to delivery.

So SNG001 going into US home trials is very exciting as we have the preffered delivery system already.

Couple this with it being the best looking treatment with potetnial to fill drug need at WHO ord scale 3/4 and its potential to prevent long covid cases it is very well postioned.

Yes Fleccy thats what I was saying Phizer/Moderna stand to profit massively by selling into Western countries so its in their interest to influence/lobby FDA, media and key parties.

AZN have done themselves no favours by claiming the 90% number knowing they only trialed it in the under 55's and in the UK. I can't see how Western countries populations will want the vaccine. Who will want a vaccine with 62-70% efficacy over one that has 95%?

Unless things change I can only see AZN rolled out across the poorer countries at this point.

Another day on reddit private group for most of the long term people I see :)

On all probability it must be 30 on trial currently taking treatment.

From the numbers in my previous post. The worst case scenario would need to assume for 7 months we had zero uptake on the trial. Although possible this has to be very unlikely.

Its hard to tell if he meant 30 enrolled currently taking treatment or he meant 30 currently enrolled in total for the trial.

RM said they had virtually no takeup over summer and since October have been getting 1 or 2 a day on average. When he says October most thought he meant Oct 1st maybe he meant from Oct 31st! Stephens interview was Nov 19th so using 1 or 2 a day on average of 30 gives us around 20 days to fill maybe? So it could take us back to Oct 31st.

The 30 number would also need to assume we had zero takeup since the trial began what 8 months ago. That surely cant be the case?

I honestly don't know the answer :)

More bad news for AZN vaccine

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html
main stream

https://twitter.com/EricTopol/status/1331708429866450944
'The odds of regulators in the US and elsewhere quickly EUA ...are declining, an unexpected setback'

https://twitter.com/davidenrich/status/1331741789619941377
This bit is a new revelation in the story
'A top AstraZeneca executive in an interview just now with @nytimes, he defended the company's decision to provide info to Wall St analysts but not the public and to not disclose a key error in their testing process.

AZN need to perform some damage control here as the story in the USA is spiraling and going more main stream.

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html
main stream

https://twitter.com/EricTopol/status/1331708429866450944
'The odds of regulators in the US and elsewhere quickly EUA ...are declining, an unexpected setback'

https://twitter.com/davidenrich/status/1331741789619941377
This bit is a new revelation in the story
'A top AstraZeneca executive in an interview just now with @nytimes, he defended the company's decision to provide info to Wall St analysts but not the public and to not disclose a key error in their testing process.

Thanks for the Holgate link - Listen from 9:30 - 11:30 onwards. Genetic susceptibility in the interferon pathways and autoantibodies. Holgate mentions potential of precision treatments for these people with inborn errors. This ties in with the post yesterday.
***
Remember these breakthrough articles reported by the Casanova lab / COVID Human Genetic Effort people?

Autoantibodies against type I IFNs in patients with life-threatening COVID-19
https://science.sciencemag.org/content/370/6515/eabd4585

Inborn errors of type I IFN immunity in patients with life-threatening COVID-19
https://science.sciencemag.org/content/370/6515/eabd4570

Well the science has developed further with regards to people with these inborn errors and interferon response.
https://twitter.com/ShenYingZhang1/status/1329458223972225026
https://www.jci.org/articles/view/134529#.X7aWeHEIxJE.twitter

'Human TLR3 controls cell-intrinsic basal IFNb antiviral immunity. A mechanism may underlie the susceptibility to various viral illness in people with inborn errors of the TLR3-IFN pathway: HSV-1 encephalitis, Influenza pneumonia, COVID19 pneumonia, etc.'

This is no longer just Covid19 these inborn errors can determine how bad your intial response is to all sorts of viruses. So as this science develops we may find an Inteferon Beta therapy is going to be even more useful.

Whats also interesting is a certain Professor we know gave a speech yesterday to the worldwide members of the Covid Human Genetic Effort - https://www.covidhge.com

Potentially we are seeing a broad spectrum antiviral have a targeted approach. If you can test people who have these inborn errors there is a ready made drug available that will have a dramatic impact.

TLR3 info - https://en.wikipedia.org/wiki/TLR3

Disclaimer - Lots of science orientated reading.

https://www.pnas.org/content/early/2020/11/24/2012197117

The science has developed further with regards to the function of interferon. They now know an interferon stimulated gene CH25H is very important in its anti viral properties vs Covid-19. Very difficult paper to read but worth it.

Part extract

Cholesterol 25-hydroxylase (CH25H) is an interferon (IFN)-stimulated gene that shows broad antiviral activities against a wide range of enveloped viruses. Here, using an IFN-stimulated gene screen against vesicular stomatitis virus (VSV)-SARS-CoV and VSV-SARS-CoV-2 chimeric viruses, we identified CH25H and its enzymatic product 25-hydroxycholesterol (25HC) as potent inhibitors of SARS-CoV-2 replication. Internalized 25HC accumulates in the late endosomes and potentially restricts SARS-CoV-2 spike protein catalyzed membrane fusion via blockade of cholesterol export. Our results highlight one of the possible antiviral mechanisms of 25HC and provide the molecular basis for its therapeutic development.

Yes Bruce I read them obviously you don't!

Latest RNS
Southampton, UK,: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, announces that it was informed on 13 November 2020 that Leonard Licht, a private investor, now holds less than 3% of the Company’s issued share capital.

This does not say he sold all - he went below the 3% threshold. That is very different!

He had 6.5 million shares in October so that Bloomberg report must be factually incorrect. Do you have a link to that Bloomberg report David? Thx

He has regularly top sliced his investment periodically in Synairgen and has been reducing his stake from July. With the vaccine news I suspect he took another huge slice out of his holdings.

I would expect he still has partial stake left in Synairgen to take any rewards from P3, that based on his previous behaviour would be my best guess.

All we will know is LL has dropped below 3%. He may have between 0 - 2.9% shares left.

No way of knowing unless we ask LL himself.

Exactly Phizer/moderna and any other US related company with a vaccine are going to apply pressure on the weak data. After all their vaccines cost up to 10 times more than AZN's!

AZN largely doing this at cost whereas the others stand to make alot of profit.

Thanks for the link Shemar.

Looking at the P3 trials the drugs they are mainly for severe stage disease. Many are inhibitors, Anticoagulant etc. There are very few drugs that target early stage hospitalisation. Some like Remdesivir and plasma have now been largely discredited.

The many mAbs listed have been given EUA only for pre hospitalisation so although they are in direct competition for this stage of disease with SNG001 they are not for Stage 3 and 4 of the WHO ordinal scale.

As many including Fauci has said there is nothing good yet for the early hospitalisation phase. Your link to that website confirms this is the case.

Disagree FDA and other approval boards are unlikely to approve the vaccine in the current trial state. No news over here in the UK about the vaccine but if you check USA and the academics over there they are not happy. There is lobbying going on from ex Phizer presidents etc discrediting the results and people saying the 90% number has been inflated.

Number of issues with 90% claim have materialised -
Half/Full dose only materialised due to incompetence and a major mistake during dosing.
Approx N= 2500 for this group. (Very low number)
No one over the age of 55 was included in the half dose group.
There are also many other potential cross over of protocols.
We do not know full subgroup data. eg Were majority in 18-30 age range? Were more men? etc

So AZN have a choice with FDA approval. The talk is they can either
a) Submit full data for original full double dose regimine (62% effiacy, lower 95% CI 42%), as yet we do not know what the over 55 age group data is etc.
or
b) Extend the numbers in the half dose group by 5k and include the over 55s. Then you can see a more accuracte efficacy number.

Media are hiding this over here in the UK at present. Keep an eye over the pond as this story could get bigger once more data emerges. The AZN vaccine has the potential to have considerably less efficacy to Phizer/Moderna.

Almost certain from 7th Jan onwards we will see a huge 3rd wave. 5 days of household multi generational mixing whilst ****ed isn't going to end well. Not just Covid to contend with theres a high chance of other illnesses out in force like flu etc. NHS is going to struggle.

Also learning some EU countries having similar xmas holidays from the pandemic. Utterly mad.

Vaccines aren't going to help and rollout plan will likely be hampered.

The 90% number is *******s. Once you add in proper age groups this will drop significantly

Competition for a vaccine is hotting up, US based companies stand to profit more if AZN vaccine not approved. Expect some lobbying going on to hammer AZN for their dodgy data.

This story is getting bigger in the USA, I wonder if the BBC or any other media will even bother reporting it tomorrow.

As you say our vaccine body will no doubt approve it ;/