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It does sound as if this is very early/small data set.
They will be submitting the data they have in 3rd week of November for 'emergency use' based on the minimum safety data period required by FDA.

I thought emergency/compassionate use was for life threatening conditions with no other treatment available.
Not clear to me what situations require 'emergency' administration of a relatively untested vaccine to healthy people.

I suspect FDA may need more data and take longer than they hope to give approval for a vaccine in healthy people in spite of the urgency of the pandemic.

From what I can see the Lancet is weekly and on a Thursday. No mention of SNG001 in the current edition from last Thursday, so hopefully one Thursday soon.

Agreed though, all credit to bagitup and I think Bella. Don't think for a moment they are making this up, but we shouldn't let excitement run away with us. May be Lancet space is filled for a few weeks ahead or something got lost in translation.

May have trouble sleeping with the excitement though!!

Since 20th July we have been very excited about the potential for SNG as a treatment, but various reports or views from scientists have contained comments like 'scientists are sceptical', 'nothing has been published', 'has not yet been peer reviewed'.

Action has been taken very quickly behind the scenes with progressing trials. I do think that a Lancet publication of the P2 results (hopefully true) will be a massive piece in the jigsaw. We may then see everyone talking about SNG and realise this is what we were waiting for and there is no conspiracy.

I can't wait to see if we are really published this Thursday.

Great information Bagitup!!

The Lancet is the or one of the best journals for medicine, so must have had excellent reception if it is accepted there. From what I can gather it seems to be published on Thursdays. So exciting..

Trying to think of possible timelines here. RM made clear that they are progressing this as fast as possible!

From Joey Diamond's post. First they need IND, then need to wait for 30 days before they can start the trial. Once they have IND they can apply for EUA for people not eligible for the trial.

So, if they anticipate a November start, they expect IND by next week. Hopefully this would be worthy of RNS.

The trial is said to be randomised placebo controlled, but not double blind. This seems to mean the clinicians will know who is getting SNG001 and who is getting placebo. As the trial progresses it will be clear how well it is working and possible to do early analysis and maybe stop the trial for benefit.

So, we certainly may see EUA much earlier than the final P3 results. Maybe even full approval much earlier that final P3 results if stopped for benefit. The need for SNG001 will be more and more desperate as the winter progresses.

Looks like the AIM award winners will not be announced until December after a media campaign now.

http://www.aim-awards.co.uk/media-room/

Rasher you are talking rubbish. There have been pandemics through history and quarantine has always been part of the response. The word was coined from the 40 days ship cargoes were held in Venice during the plague. You are entitled to hold views which most people find very offensive. However please try keep your facts somewhere close to the realities of history.

Volatility posted it earlier - not found by me!
Sums are a bit of a coincidence though.

Link to video posted earlier by volatility. see 13mins 30.
https://www.youtube.com/watch?v=BzK7lCjN6Jw

So maybe fundraise up to 160 million shares at £3 per share to fund massive production and sales, then takeover at £8 billion. So £50 a share exactly. Nice to have a dream!

Yes, interesting that the amazing Numis target of £50 per share is almost exactly the £8 billion mentioned by RM for post approval valuation of the company. Perhaps he has very clear goals!

Hello, this is what I sent (on 29th September) if helpful to anyone else. I kept it short as am sure MPs get so much volume of email.

Dear MP,

We are now progressing into a second wave of the Covid pandemic, with unbearable costs in terms of health (physical and mental) of the UK population as well as devastation to the economy.

There is mounting evidence that Covid works by suppressing Interferon production (an early part of the immune response). Two papers published in Science last week show that many people with severe illness either have antibodies to Interferon or genetic mutations rendering their interferon response less effective.

This increasingly raises interferon treatment given early in the illness as having huge potential to reduce illness severity. The Southhampton based company Synairgen is currently trialling their nebulised Interferon beta treatment, with excellent results in a study of hospitalised patients. Their trial of 'at home' treatment to evaluate whether this treatment can prevent illness progression and need for hospital admission is currently struggling with recruitment in the light of government support (as per their RNS of today).

I am shocked that there is allegedly a plan to spend a further £100billion of UK citizens' funds on operation Moonshot, while failing to support assessment of this treatment which could be a game changer if given early in Covid infection.

Please could you place pressure on the Government to precipitate support for assessing this treatment (perhaps through the RECOVERY trial) with a view to urgent licencing approval if data supports efficacy.

Thank you for your help in this matter.
Yours sincerely,

Yes, I do live in a 'shadow' constituency. Was very impressed by how informed he seems to be and supportive of advancing interferon as a possible treatment though.

May be we really can exert pressure and spread the word to speed this up if more of us write to MPs. I expected to just get a fobbed off reply.

Just got this response from my MP - every little helps after all!

Thank you for your email, which I have forwarded to the shadow health team. I am aware of studies suggesting a link between auto-antibodies to endogenous interferons and COVID-19 severity among patients. I believe this emerging body of evidence provides another means of identifying at-risk groups. I also think that the Government should now consider all available evidence around the effectiveness of beta-interferon for use in treating COVID-19 with a view to urgent licencing approval should evidence indicate this would be an appropriate course of action.

Once again, thank you for contacting me.

Best wishes,

There is an obligation to update price sensitive information to the market.
If AFC think this standard of communication meets their obligations and any standards of professionalism it might be
because what they have to say about Alkamem is not positive enough to move the share price and be defined as price sensitive.

RM is doing a great job of getting SNG001 available.
For a tiny company to take a drug this far alone is truly remarkable.
Well done Synairgen.

But, these diagrams about the best use for Interferon early in the infection make a lot of sense. We may be the holy grail of treatment as early a possible, rather than restricted to treating only very sick people. We really need progress on the home trial. I have written to my MP asking what the government is doing to support progress of this trial.

I would like to see SNG001 available immediately to everyone with a positive test result. Hopefully a vaccine will be cavalry, but in the meantime and even with a vaccine.

UK population abour 60 million.
Before 70% herd immunity about 42 million.
Some will be asymptomatic and never be tested diagnosed, so maybe 30 million positive tests.
At £1400 per treatment, this would cost £42 billion.
Very cheap compared to current economic carnage and operation moonshot allegedly another £100 billion of our hard earned.

If this meant people were kept out of hospital and could feel that getting covid with treatment was as scary as flu currently is we could return to more normal life and economy.

Please support the home trial Uk Government!

Good point Mouchers.
This sounds like excellent progress and Alkamem really could be the holy grail for AFC.

If the presentation is restricted to information currently in the public domain about Alkamem it will be very short.
If it is to include information not currently in the public domain the presentation needs to be made public at the same time, or the attendees will need to be added to the AFC insider list and unable to trade in AFC shares. Failure to do this would be a matter for the FSA.

I hope AFC will be meeting their legal obligations.

I only partly agree with you Tornadotony.
I know you are very well informed and respect your posts.

However, scientific peer reviews are there to be very critical of the science. We know they will say the study is small and the groups not completely matched for comorbidity. They may also nit pick about things like statistical analysis not including multiple comparisons.

This is a different thing from does the drug have benefit and do more harm than good required for it being used. The tie up with Clinigen required due dligence and it is already a vote of confidence to get this far. We may or may not get approval without further trial data (hope we will), but it will not be decided based solely on scientific peer review.

I tried to spread the word about the home trial via facebook. A non-medical scientist (quite high powered) replied that the study was 'flawed' because it did not specify whether it was UK or internationally based. I pointed out that having MHRA approval was specified and defined the study as UK based in the absence of other approvals. But, we should expect peer review to be very critical, it is how science works. It does not mean SNG001 is not great or won't get approval and save a lot of lives.

This is a great RNS and happy to see this treatment with huge potential to prevent a lot of deaths and economic carnarge now available to select patients.

However, I see the most benefit potentially as a treatment early in the illness and this will need verification with results from the 'at home' trial. I can't believe that Boris plans (allegedly) to spend another £100 billion of our hard earned on 'Moonshot'. yet the at home trial is struggling without sufficient government support. I will be writing to my MP today.

Synairgen are currently getting their covid patents sorted and this IP protection is vital to get right for all territories.
For most territories this needs to be submitted before the invention is published.
So publication and the peer review associated with it needs to wait until after all patent submissions are completed.

Great perceptive post Ghia!

The proactive interview certainly gave me the impression that approvals, supply chains. funding perhaps from government, etc are very active and a priority while a partner may have been described as 'later' or 'ultimately'.

Either this is tactical to let prospective big pharma know SNG don't need shabby deals from them. Or, RM really is progressing SNG 'business as usual' as far as it can go without needing a partner. The more boxes he can tick, the higher the value when a partnership is finally agreed (or otherwise). Very exciting to see what happens next!