Member Info for JoeyDiamond

I thought you guys were talking about Kim Kardashian for a while then til it twigged haha

Bella6532 I too worried about Brexit and the implications. The German BfArM website helpfully has a dedicated Brexit part of their site I read.

https://www.bfarm.de/EN/Drugs/licensing/ZulRelThemen/Brexit/_node.html

Following the signature and ratification by both the UK Parliament and the European Parliament of the agreement regulating the UK's withdrawal from the European Union on 31 January 2020, the European Council adopted the decision to conclude the withdrawal agreement on 30 January 2020. As of 1 February 2020, the United Kingdom is therefore considered a third country. However, a transitional period until 31 December 2020 was agreed, during which the conditions and obligations of the acquis communautaire continue to apply to the United Kingdom.

So 31st Dec until Britain truly shoots their own foot :)

SirSwish1982 - Ye essentially we get to step 10. )

I have taken a look at The Spanish approval system but their site not as helpful as Germany as no English translation :)

The Spanish Medicines and Healthcare Products Agency (AEMPS) may authorize the use of medicines under investigation before being marketed in Spain

https://www.aemps.gob.es/medicamentos-de-uso-humano/acceso-a-medicamentos-en-situaciones-especiales/?lang=en

I believe the best info to be had is in this pdf
http://www.boe.es/boe/dias/2009/07/20/pdfs/BOE-A-2009-12002.pdf

It does suggest approvals can be based on EMA/Partners directives so it seems there is a good chance that once France and Germany approve they would quickly follow suit IMO. If anyone is fluent Spanish have a read :)

Peel Hunt, which had a 'buy' recommendation on the stock, left its price target of 49.0p unchanged. But Shepherd-Barron added: "There is substantial upside beyond this if expectations begin to be delivered

For the old timers here this used to be 90p a share, it then collapsed mainly due to the ATM regulatory issues. Then it started recovering only for Covid to kick it down.

We know the ATM part of the business has now recovered so I personally believe the bottom is now in and broker reccomendation seems very reasonable.

OK did some research into Germany and what their process for granting a drug is.

The main body is called The Federal Institute for Drugs and Medical Devices (BfArM) and they have a program called AMHV which is their equivalent ATU.

https://www.bfarm.de/EN/Drugs/licensing/clinicalTrials/compUse/_node.html

Now lots of great information in English on this website but something particularly cool lies in this pdf flowchart

https://www.bfarm.de/SharedDocs/Downloads/EN/Drugs/licensing/clinicalTrials/compUse/AMHV-Flow-chart.pdf?__blob=publicationFile&v=3

I wont ruin the surprise but follow the flowchart to the end and look at the implication of the French news. :)

Well if the news is indeed correct about France allowing SNG001 via ATU then we should see French Doctors requesting the treatment. From a timeline view by the start/middle of November we should start seeing initial results.

* You would expect to see excited Doctors reporting on great reductions of progression to severe disease/deaths.
* Patients with recovery stories in the media.
* IFN-B academia/discussions even more to the forefront.

The potential for the situation to explode is real. Demand will increase exponentially if word gets out of a successful therapy and puts us right in the shop window.

At this point does a big pharma take notice and do governments finally cave to the pressure.

side note
I'm going to try and research Germany as I suspect they may well approve it in a similar fashion. Germany seem to have the most sensible leadership and use science to make decisions.

https://www.cbsnews.com/news/moderna-ceo-coronavirus-vaccine-wont-be-ready-until-spring-2021/

Moderna saying their vaccine won't be ready til 2021 Q2. To me the best chance of keeping deaths down is a combination of mass testing and theraputics. Spending money hand over fist on vaccines is utterly stupid by this government.

https://polaris.brighterir.com/public/blenheim_natural_resources/news/rns_widget/story/x2n13mx

Annual report RNS

My thoughts exactly I actually said in my head a 'Solid update' haha. Glad ATM is getting up to speed.

Overall trading in the first half has been materially ahead of the Board's Covid-19 adjusted expectations Good recovery in Commercial volumes during Q2 with Netherlands now operating at 96% and Belgium at 90% of prior year Cost savings of €10m delivered during the first half.

The recovery of ATM has made good progress during the first half of 2020. An initial shipment of thermally cleaned soil (TGG) was completed in May. Further outlets of up to 1MT are in late stage discussions with the relevant authorities and some are expected to become available in the second half. New silos for filler and other storage equipment to enable the separation of cleaned soil into construction materials, like sand, gravel and filler, are being installed and will be commissioned on time in the fourth quarter. The order book for contaminated soil is building steadily but projects may be subject to delay as a result of Covid-19.

Check Boohoo share today another thats been played.

Good question Spinnaker, some more information on the process suggests around 4 weeks.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375327/PIM_designation_guidance.pdf

May be worth emailing Synairgen and asking have we already obtained or applied for the PIM. Seems a formality but will help with timelines.

Yes you would think that RNS should have come at 7am but heh no complaints here :)

Nice PDF to read from the RNS

https://www.bruker.com/fileadmin/user_upload/8-PDF-Docs/Separations_MassSpectrometry/Literature/ApplicationNotes/1881181_MT-128_SARS-CoV-2_Antigen_Assay_ebook.pdf

We have more information on timelines and manufacturing size. We have 2 conflicting reports here of very similar information

1) From the RNS today
Manufacturing Scale Up
In preparation for gaining approvals for SNG001, the Company has made good progress with discussions with a variety of international suppliers to scale up production of SNG001 rapidly, with the aim of being able to produce approximately 100,000 treatments per month in 2021.

2) From Richards interview at the Sachs meeting last week. He was on the Covid-19 therapy chat. 21:15 on the video
https://www.youtube.com/watch?v=IOHmVnttowM

Richard and the slide says
100000's (notice the plural) in the new year

From the information we can say Jan 2021 its expected we have 100k treatments at least being produced per month.

Now the price of drugs as we know vary wildy depending on what country you are in. For example Rebif a interferon beta based drug can cost $7000 in USA but around £700 in the UK.

You can see what IFN-B treatments cost in the UK here (UK has some great drug prices with the NHS deals) https://bnf.nice.org.uk/medicinal-forms/interferon-beta.html

So im sure better people at working out revenue models than me but think it around a billion per year depending on where SNG001 is sold.

No doubt we all wanted the news of a big pharma tie up or concrete news on a government deciding to help us along with approvals and giving Synairgen some of their (our) taxpayers covid cash that his been splashed around and generally ****ed up the wall. So I can understand the disappointment in some investors eyes and a drop in the SP today.

I suspect/guess Richard may be a little disappointed in big pharma/government negotiations and wanted to be a bit further along in the process. I think some pressure needed to be applied and get the ball rolling (faster).

So I think the MAP agreement is a great way to apply pressure and get SNG001 out there. One has to say the timing is impeccable. Great reasons for it

1) Gives medical staff the ability/route to give SNG001 to their patients in hospital and finally get our drug in the frontlines. Circumvents the red tape to a degree and we save lives.

2) We will gain further data. Although to note this isnt as robust as the clinical data you would get in the double blinded trial but it helps.

3) Essentially becomes a working advertisement for SNG001 amongst the leading medical Drs/experts, these people are best placed to pressure governments/regulators and pharmas. They also will see first hand the potential of SNG001 and surely it cannot be supressed much longer by governments. Reports of a miracle drug bound to surface backed up by academics :)

Why is the timing impeccable? Over last couple of weeks we have seen major breakthroughs with gene research and type1 interferons. Multiple lead academics have concluded across many countries IFN is the way to go. On the this board alone there has been many posts regarding this so its on the medical professions minds. So there is high chance of multiple orders of SNG001 via the MAP whilst Interferon is the topic of the moment in the covid therapy world.

So many different topics/clues to take from the RNS, for me personally it wasn't the blockbuster that we hoped for but some interesting points I notice we haven't discussed. I did only scan through the 30 pages or so my apologies if already discussed.

Per Protocol Population data results
PP population critieria; (positive PCR test, had taken at least two out of their first three scheduled doses and had no protocol deviations impacting on efficacy).

When you look at the PP population results alone they are actually slightly better than the original 20th July reported results.

SNG001 reduced the odds of developing severe disease or dying in the ITT population by 79% (OR 0·21; 95% CI: 0·04, 0·97; p=0·046). As quasi-complete separation of data occurred in some model covariates, an additional post-hoc, Firth logistic regression analysis was conducted. This showed there was a trend towards reduced odds of progression to severe disease or death in the ITT population (72% reduction; OR 0·28; 95% CI: 0·07, 1·08; p=0·064) that became significant in the per protocol population (82% reduction; OR 0.18; 95% CI: 0.04, 0.93; p=0.041).

So essentially patients who took at least 2 doses had an 82% reduction of developing severe disease/dying.

I think most of the leading academics in Covid research now agree that type 1 interferons are the most likely theraputic to work. I have seen trials/reports from Iran/Italy/UK/USA/China/France all coming to the same conclusion interferons are the way to go. Recently many concluding IFN Beta is the most promising just like Synairgen told us! I recently read a report that bats have high levels of interferon/immunity so they are excellent carriers of the virus but don't have any major disease.

I think the peer review is a dead cert personally now we have so many in depth type 1 interferon studies round the world coming to favourable conclusions. I think when Tom Wilkinson says this is a game changer and Richard says this is our time the science is just too compelling.

The biggest hold ups to emergency approvals such as EUA is not the actually science/saftery/efficy. For an EUA a drug just needs to show it does more good than harm when it comes to Covid-19, as one Dr said you could put forward leeches for EUA and it would satisfy this criteria.

The big problem in obtaining an emergency approval in a pandemic is you have to prve you can manufacture the drug in huge quantities quickly and distribute immediately. Obviously Synairgen requires huge scale up and major distribution channels. As Richard has said multiple times they need to team up with a big pharma.

So government/regulatory bodies can't approve until its confirmed the supply chain is in place to support mass production of SNG001.

SP just tagged 25 live. Facts are in the SP.

I posted earlier this morning and was attacked by many when I said the RNS wasn't great. SP just hit 37 as I write.

VAL may have a successful drug in the future but the likely timeline IMO is 10 years to market once you factor in the additional P2 and a P3 trial are required. Not many traders want to keep their money tied up that long especially with a risk of placings on the horizon to fund said trials if no pharma partnership.

I feel sorry for the newer holders who have bought in recently probably on basis of the usual rampers who I suspect have now all exited whilst saying £1 up next / wonderful RNS / Just topped up

The drug has demonstrated safety at lower doses no one disputes that but the primary outcome failed as they haven't determined/estimated what the maximum dose is. Ive linked the direct evidence.

Suzy says
With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate."

So we have confirmation that more trials are required. The current trial of 12 took 6 years so logic dictates a similar trial will take just as long.