Member Info for JoeyDiamond

I may be being a bit dim but how do you register a question for the event? Or do you just ask the question as the event is ongoing bit like Ste Holgates?

I would love to hear RM's and SH latest thoughts with regards to the high efficacy of the vaccines and how they may or may not impact Synairgen.

Mumbo_Jumbo thats a good spot. Very strange numbers and statistically very slim chances :)

Not all good news

People in the vaccine arm were more likely to develop severe covid. 1 in 8 people in vaccine developed severe covid vs 1 in 18 in placebo. Thats something that needs to be checked.

With no RNS this morning, I think the seminar later will be a similar presentation as the II's got at the placing.

Be interesting to see if he he repeats the expected trial start will be in November.

People who think we will need to wait a year for results are nuts.

Look at the end points in the trial. 28 days of data is required.

We need to recruit 45 patients at each NHS site at ORD scale 4 of the disease which is at the early hospitalisation phase (Not ICU). The trial is marked as urgent need and has lots of cash and various 3rd parties supporting it.

Even if we only recruited 20 people per hospital which should be easy considering covid infections currently we could have initial readout data within 1 month of the trial starting. If the initial data replicates the P2 trial it should be enough to get EUA.

This is why Richard has said he expects we could get this done in 2 months with the huge resources thrown at it.

The key thing is knowing the trial start or the date of when 1st patients are getting dosed. We then have a timeline we can all use.

https://www.proactiveinvestors.co.uk/companies/news/934205/astrazeneca-to-release-covid-19-vaccine-data-imminently-says-jefferies-934205.html

'Interim results from the final stage of trials in the UK, Brazil and South Africa should come in “days to weeks”, as management already guided for figures to be released by year-end.'

So timeline wise, some time next week is my estimate for another big vaccine announcement, probably 96% effective no doubt lol :)

https://www.sciencedirect.com/science/article/abs/pii/S1934590920305488?via%3Dihub

Small study showing if you smoke you are more likely to develop Covid-19.

Interesting line

'Single cell profiling of the cultures showed that the normal interferon response was reduced after cigarette smoke exposure with infection'

The other theory is Rebif is being given its final push to coincide with the SNG001 trial to compare outcomes using the same endpoints. A great way to see if the method of delivery of interferon makes a big difference.

Either way its exciting the trial end date is showing as 15th December and that SNG001 has in some way influenced the design of this trial.

Yes Prion25 the trial is adaptive so you can add/remove interferon drugs as you see fit. The outcomes have been changed to resemble Synairgens design.

With whats gone on with FDA / IND / P3 trial / NIHR / 20 countries etc just seems a massive coincidence to me.

I wonder if this change in the ACTT-3 trial in the USA is why we are now seeing 900 patients across 20 NHS sites rather than countries.

The ACCT-3 trial is recruting ppl from USA, Japan, South Korea, Mexico, Singapore

Just a big coincidence? Or is it possible there are 2 trials running now?

The USA has a major trial called Adaptive COVID-19 Treatment Trial 3 (ACTT-3). This trial has been running investigations into Interferon beta-1a/Remdesivir.

Now this trial still says its using Rebif but with recent WHO trials IFN-B via subcutaneous injection didn't work.

Take a look at all of the recent changes

https://clinicaltrials.gov/ct2/history/NCT04492475?A=27&B=28&C=Side-by-Side#StudyPageTop

a) Primary completion date
b) Recruitment completed
c) Change in the outcome measures
d) Ordinal scale requirements

This trial has been made to be very similar to the Synairgen P3 design.

Sooo
FDA running Rebif in conjunction to see its got efficacy when other trials have said no.
or
The IFN-B agent is SNG001 (Just the trial has not yet updated the agent?)

Hmm, one to keep an eye on.

Im sure the FDA would be happy with UK trial data as the Recovery trials in the UK are seen as the worlds best, largely due to the NHS setup. As many US commentators have said the UK national trials are better than its US equivalents.

Take Dexamethasone as an example - FDA gave approval for it based on UK data.
Take hydroxychloroquine study as an example of removing approval based on UK data.

So I suspect during IND discussions with FDA they are happy to use UK data for 900 people to grant approval. I think this may be the reason why the 20 countries may have changed to 20 NHS sites.

Hopefully we find out more tomorrow on the trial designs!

Yes Org Asian culture definately has been a factor in beating the virus.

'I hope everyone appreciates that the only way for normality after this is a vaccine. '

Wine you are completely wrong, real world examples say otherwise.

Look at all the successful countries who have quickly brought Covid under control/eradicated. None of them have a vaccine they all used a combo of mass testing / tracing with population measures such as masks/distancing

Look at Taiwan for the gold standard response. Other countries like New Zealand, Japan, South Korea, Thailand also have few if any cases now.

Slovakia are doing country wide testing and have cut infections by half in a short period of time.

Headline is a bit misleading as leaves out key word 'supports'

From the text
UK-based biotech company Synairgen has announced that a small phase 2 trial of its investigational candidate SNG001 supports advancement into phase 3 testing.

Timeline makes sense it will have been 35 days from the update about proposed IND submission to the FDA and as we know FDA like up to 30 days to review. Peer review complete and NIHR/Oxford posting news on their website on the P3 trial does seem news is imminent.

I will be honest I will be disappointed tomorrow if no RNS :)

We need some Richard Marsden plasmablasts in response to the SP.

Haha that should say more good than harm :)

The vaccines will almost certainly both be authorised by EUAs long before peer review or any of the longer term immunity information is known/proven. FDA set 2 months of safety data as the requirement for EUA which they will have accumalated this in the next few days/weeks. EUA efficacy just needs to show it does more harm than good.

Most of the scientists predict start of December for EUA.

So essentially vaccines are going out to people where we have no idea if they give lasting immunity (we know they give 14 days protection so far). As Michael alludes to what happens after our plasmablasts bugger off is the key question :)