DNTC
I wouldn't worry too much about the situation with 212. No-one can value the Stem shares at the moment., The price will be set by the market so I can't see that the platform can determine a price for the shares until trading commences which seems as though it will be a month or more after the split, (assuming no buyout).
However bear in mind that if Stem shares are worth £1.30 at the moment that puts the rest of TILS at 7p which is an under-valuation IMO. Even if the built in price is less that now but £1.30 when trading commences the PV of the STEM element of the TILS SP shouldn't be much less now (maybe 30-50% discount). It is discounted of course not only due to the fact that investors will not have access to part of their money for a month or two after the split and the contemporaneous reduction in TILS SP but also the concerns that it may never happen. However given the current SP and its limited movement since the announcement of the demerger it doesn't appear to me that investors are putting a whole lot of value on Stem at present.
That sounds a bit confused I am afraid but it is bedtime.
Best wishes
Spinnaker
I had a small holding in BRH up to a few months ago. I sold at about 50% loss. A lot of negative comment at the time particularly from Doc Holliday. Feeling that the BoD were self serving. Not unusual on AIM.
There has been a fair bit of action over the past couple of weeks and obviously a couple of positives in the pipeline but I am wary of revisiting. Coincidentally the share price now is about what it was when I first invested just before the peak.
Spinnaker
Can anyone enlighten me as to the details of this. I attach an extract from Wikipedia below but I am not sure if this is relevant or correct. Is there a difference between 'EAMS' and 'MAP'?
'
'Europe
In Europe, the European Medicines Agency issued guidelines that members may follow. Each country has its own regulations, and they vary. In the UK, for example, the program is called "early access to medicine scheme" or EAMS and was established in 2014. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation. If that designation is approved, the data is reviewed, if that review is positive, the National Health Service is obligated to pay for people who fit the criteria to have access to the drug. As of 2016, governments also paid for early access to drugs in Austria, Germany, Greece, and Spain.[1]
Companies sometimes make use of expanded programs in Europe even after they receive EMA approval to market a drug, because drugs also must go through regulatory processes in each member state, and in some countries this process can take nearly a year; companies can start making sales earlier under these programs.[1]'
Does anyone know iof we have 'PIM' status or have applied for it? If we have this then WIKI says the NHS is obligated to pay for the treatment if requested by Doctor/patient. Is this right?
Many thanks
Spinnaker
Jatw
Thank you for your response to my post. I note what you say. The ' Wiki' extract below seems to imply that the NHS will pay if the treating doctor agrees with the patient that it is an appropriate drug and/or there is no alternative treatment. I have heard previously that the NHS and private medicine cannot be mixed and therefore whilst under NHS care a patient or their insurers cannot pay for/ provide a non NHS treatment. I would also expect that the NHS would seek to prevent an ill or infectious patient discharging themselves. Also there were not any private hospitals taking Covid patients in March or since.
If this is the case then the patient won't be able to have and pay for SNG001 if the NHS won't fund the supply. Am I correct or perhaps you or another knowledgeable poster can enlighten me as to the correct position?
I attach an extract from the Wiki entry which states the NHS would pay but this may be incorrect or outdated.
Many thanks
Spinnaker
'Europe
In Europe, the European Medicines Agency issued guidelines that members may follow. Each country has its own regulations, and they vary. In the UK, for example, the program is called "early access to medicine scheme" or EAMS and was established in 2014. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation. If that designation is approved, the data is reviewed, if that review is positive, the National Health Service is obligated to pay for people who fit the criteria to have access to the drug. As of 2016, governments also paid for early access to drugs in Austria, Germany, Greece, and Spain.[1]
Companies sometimes make use of expanded programs in Europe even after they receive EMA approval to market a drug, because drugs also must go through regulatory processes in each member state, and in some countries this process can take nearly a year; companies can start making sales earlier under these programs.[1]'
Hello everyone.
I am not a holder here but have just come to have a look at your board since I am a shareholder in Synairgen. There is a fair bit of frustration amongst SNG PIs that the potentially game changing nebulised interferon drug, SNG001, repurposed for Covid-19 treatment has had a fantastic result for the hospital element of the Phase II clinical trial but the home treatment element of the trial has not yet been filled even though access is available nationally. Also there has been no news about a Phase 3 trial here or abroad.
The SP has dropped further today following the RNS concerning MAP and Clinigen tie up but it is good to see CLIN SP has reacted positively. I have little knowledge about MAP but it appears CLIN is experienced with supporting drugs in this field and this should be helpful in getting SNG to patients who could benefit greatly in the short term and ensuring all hospitals and doctors here and across Europe have the knowledge of the likely benefits to patients and a chance of accessing this currently singular treatment available for Covid patients prior to intubation.
I am hopeful that CLIN can help SNG save numerous lives this winter. Good Luck to all patients and shareholders.
Spinnaker
Thanks for the interesting info.
I thought initially that the NHS would not be able to use the drug under this protocol and it would be limited to private hospitals. That would be no good because in the first wave there were no large numbers of Covid patients being treated privately.
However this extract from the Wiki entry link posted by pmjh for MAP shows that is not the case.:-
'In Europe, the European Medicines Agency issued guidelines that members may follow. Each country has its own regulations, and they vary. In the UK, for example, the program is called "early access to medicine scheme" or EAMS and was established in 2014. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to the Medicines and Healthcare products Regulatory Agency and apply for what is called a "promising innovative medicine" (PIM) designation. If that designation is approved, the data is reviewed, if that review is positive, the National Health Service is obligated to pay for people who fit the criteria to have access to the drug. As of 2016, governments also paid for early access to drugs in Austria, Germany, Greece, and Spain.[1]'
There are a few hoops to go though and presumably that is where Clinigen can help.
Spinnaker
Page 3 draft 2
We don’t have that much time and if we are to prevent a further massive death toll I would ask you please to consider putting pressure on the Health Secretary, the government and PHE to allow this drug to be used experimentally in the NHS system obviously with detailed checks on each patient so that further clinical information can be obtained in real time under emergency procedures. This process could form part of a Phase III trial. Also government funding should be given to enable any procedural hurdles to be overcome quickly and set a wartime equivalent footing for production and distribution in the expectation of a huge take-up requirement throughout the nation by hospital doctors, GPs and infected people in ‘at risk’ categories when the treatment receives approval. This is a massive opportunity for us (both the UK and the rest of the world) to come through the pandemic whilst minimising serious illness and death, hopefully avoiding a second lockdown whilst keeping the NHS functioning all at minimum cost.
This is a link to an interview given by Richard Marsden CEO of Synairgen Plc on 8th September 2020 which you may find helpful.
https://www.proactiveinvestors.co.uk/companies/news/928518/synairgen-unveils-positive-data-from-phase-ii-chronic-obstructive-pulmonary-disease-trial-928518.html
Your help would be beneficial to advertise the availability of places on the at home trials for citizens over 50yrs and/or with co-morbidities who have received a positive test and apply within seven days of symptoms appearing. http://www.covidtrialathome.com/
This drug has the potential to save countless lives and enable us to reopen our economy to the benefit of us all.
I have written this letter intending it to be an open letter and will send a copy to the Health Secretary, the Prime Minister and various media channels.
Many thanks
Page 2 Draft 2
Early activation of the immune system has been shown to reduce lung damage, collateral damage to other organs and also help to prevent the deadly ‘Cytokine Storm’ which has killed many.
This link gives details released July 20th 2020 of the Phase II double blinded clinical hospital based trial of 101 hospitalised Covid patients with placebo treated control of half the group. https://www.lse.co.uk/rns/SNG/positive-results-from-trial-in-covid-19-patients-fihvg7kkd3390v1.html ‘The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo’. I think anyone would be impressed by such a drug that would reduce the incidence of severe disease by a factor of almost five.
There is currently an extension of this trial being undertaken in the UK with at home elderly and high risk patients being sought for self- treatment of early infection. Due to lack of awareness exacerbated by the patchy testing availability and slow speed of results this has not yet been filled as far as I am aware. The expectation of scientists working on this is that this treatment, if administered pre-hospitalisation is likely to have a profound and significant effect in reducing the likelihood of hospitalisation being required. Also it would have the massively positive effects of reducing the severity of the disease and subsequent ICU requirement, intubation and death and help prevent hospitals filling up with Covid patients over the winter.
The product, by boosting the immune system will also most likely have a beneficial on influenza patients whether or not they have co-infection of Covid. SNG001 efficacy is not diminished by concurrent cortico-steroid treatment, clinical conclusions from COPD trial.
The government has spent millions on the search for a vaccine but even if discovered this will not be perfect; take-up may be low and it probably will not be in place before late 2021. Apart from availability of speedy testing which number on short term priority, the UK and the world needs an easily administered treatment that is effective in the early stages.
As you will be aware the normal validation process for a new drug or medical treatment is long-winded and expensive. The next step for SNG001 would normally be a full Phase III trial involving perhaps 1000 people. The product has been shown to be safe over many years during its use in COPD and asthma trials and is well tolerated by the body firstly because it is an innate protein and secondly because dosing by nebuliser is direct to the lungs and requires much lower dose requirement than I/V or injection which have both been tested on patients. I am not aware of any significant side effects for the inhaled version.
Thanks for the feedback particularly marlow.rupert and Sparkle1. I have made some of the suggested amendments and made some of my own alterations and have posted the revised letter below. Sorry I am too knackered to try and precis it down to one page but others can.
I also note the differing views about the use of writing to MPs and agree that probably lobbying influencers would be very useful. I will send letter by email to contact suggestions and others can write their own, nicking any bits of this they want. I have no knowledge of Twitter or any other social media so I am sure others are better placed than me in this regard. They may even know some 'influencers'. If so please do it.
I am frustrated that there has been no concentration by the government on any treatment. Only vaccines, testing and PPE.
DRAFT 2
I haven’t received a reply from my last email of 4th August to you about airport testing but no doubt you are very busy at present with current problems and planning for the severe repercussions that will be coming due to the countrywide second wave breakouts of Covid infection right now and just prior to the winter ‘flu’ season.
It is vital that we do not allow our hospitals to be overrun with Covid patients for a second time, many of whom will unfortunately and totally unnecessarily die due to lack of effective treatment. I would like to draw your attention to various links below that will help you to corroborate the contents of this letter and assist with your research into Covid-19 treatment.
There is currently only one treatment available in the UK as far as I am aware. This is Dexamethasone which I understand has been shown to have a positive effect in patients requiring oxygen and ventilated patients. https://www.gov.uk/government/news/world-first-coronavirus-treatment-approved-for-nhs-use-by-government This does not prevent serious illness since it is only effective when patients are already seriously ill and likely to have long term health implications if they survive.
Fortunately, there is a natural product that has been worked on for 15 years by a team of scientists out of Southampton University, initially to help asthmatics, subsequently COPD patients and latterly repurposed in the fight against Covid-19. This product has the unprepossessing moniker of SNG001. It is a nebulised inhaled preparation of Interferon Beta 1a. This protein is an important part of the first line of the human body’s defence mechanism. Interferons are present in the blood of healthy people but the levels of interferons reduce with age. This is the main reason why elderly people are more vulnerable to severe symptoms and death following Covid infection than younger people . Not only this, but the Covid 19 virus has been shown to prevent release of further interferons by cells that are infected with the virus. This virus therefore effectively disables the body’s first line of defence enabling its swift multiplicatio
Draft letter cont.
The government has spent millions on the search for a vaccine but even if discovered this will not be perfect; take-up may be low and it probably will not be in place before late 2021.
Apart from fast testing which is a priority, the UK and the world needs an easily administered treatment that is effective in the early stages.
As you will be aware the normal validation process for a new drug or medical is long-winded and expensive. The next step for this would normally be a full Phase III trial involving at least 1000 people. The product has been shown to be safe over many years during its use for COPD and asthma. I am not aware of any significant side effects for the inhaled version.
We don’t have that much time and if we are to prevent a further massive death toll I would ask you give consideration to putting pressure on the Health Secretary, the government and PHE to allow this drug to be used experimentally in the NHS system obviously with checks on each case so that further clinical information can be obtained in real time under emergency procedures. Also government funding should be given to enable any hurdles to be overcome quickly.
If I caught Covid, particularly being aged and a mild COPD sufferer I would be very upset if I could not obtain this treatment as early as possible.
I have invested some of my Isa savings in this company since I consider this is likely to be one of the safest and most effective treatments available for dreadful Covid disease.
I have written this letter intending it to be an open letter and will send a copy to the Health Secretary, the Prime Minister and newspapers.
DRAFT
I thought I'd have a go at a letter. Draft below. Any comments gratefully received.
Spin
I haven’t received a reply from my last email of 4th August to you about airport testing but no doubt you are very busy at present with planning for the severe repercussions that will be coming to the country due to the countrywide second wave breakouts of Covid infection just prior to winter.
It is vital that we do not allow our hospitals to be overrun with Covid patients for a second time, many of whom will unfortunately and totally unnecessarily die due to lack of effective treatment.
Fortunately there is a natural product that has been worked on for 15 years by a team of scientists out of Southampton University initially to help asthmatics and subsequently COPD patients and latterly repurposed in the fight against Covid-19. This product has the unprepossessing moniker of SNG001. It is an inhaled preparation of Inerferon Beta 1a. This protein is an important part of the first line of the human body’s defence mechanism. Interferons are present in the blood of healthy people but the levels of interferons reduce with age. This is the main reason why elderly people are more vulnerable to severe infection and death than younger people. Not only this, but the Covid 19 virus has been shown to prevent release of further interferons by cells that are infected with the virus. This virus therefore effectively disables the body’s first line of defence. Early treatment with inhaled SNG001 assists the body to naturally attack the virus with the various elements of the immune system. This will also help to prevent the deadly ‘Cytokine Storm’ which has killed so many.
You will find details released July 20th 2020 of the Phase II clinical trial of about 100 hospitalised Covid patients hospital trial with placebo treated control of half the group by using any search engine. I think anyone would be impressed by the overall 79% clinical improvement shown by the treatment. There is currently an extension of this trial being undertaken in the UK with at home patients targeting earlier treatment but due to lack of awareness and lack of government support exacerbated by the patchy testing availability and slow speed of results this has not yet been filled. The expectation of scientists is that this treatment, if administered pre-hospitalisation is likely to have a profound and significant positive effect on reducing the likelihood of hospitalisation being required. Also it would have the massively positive effects of reducing the severity of the disease, intubation, death, likelihood of ‘long Covid’ symptoms, and prevent hospitals filling up with Covid patients over the winter. The product, by boosting the immune system will also most likely have a beneficial on influenza patients whether or not they have co-infection of Covid. This would mean that other normal hospital work would be able to continue.
The government has spent millions on the sea
Metaltiger
Please smack your keyboard. It seems to be very keen on extra ffs. I counted 13 too many. I have worked out what I think you mean by 'would off took' but it certainly isn't English. Try '...would have been happy with...'
Quite a difficult to read post but I have your drift.
I recall seeing an interview with Cathal some months ago when I first invested. He was at pains to explain this was a service company, HVivo included, and therefore should be a slow and steady earner rather than a potential multi-bagger. It may be that there are over heightened expectations for SP increases.
Spin
This is the second link
https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/comparing-efficacy-and-safety-of-inhaled-sng001-to-placebo/
Maxi-miser
I just checked Dibs link and the statement is concerning the Asthma phase 2 trials from March 2010. At least when I clicked on the inhaled interferon B link it took me to an NHS web post from that date.
So seems rather out of date tbh.
Spin
Just checked this board to see if anyone has posted. Since I bought in at 16.5p this SP has dropped like Tiziana every day. Just now a sudden 7% increase. No idea why!
Congratulations Ghia and to mum. Have a great family life.
My two daughters have a child each now and I suggested they do that. One has just opened a junior ISA today with HL and I said I would put some money in. I will definitely buy a few SNG shares for the bairns. The shame is , being old, I won't know how the shares fared in 18 years time!
Thank you all for responding.
I understand that KS may well be bound by an NDA and very much hope this is the case.
BMo3 The reason I am disappointed is that KS's response particularly specified R & D news due. To be honest this is not what the market is really waiting for. The last RNS relating to a patent for a monoclonal antibody was not well received by the market as far as the SP was concerned. I find the delay in any news re the main LSE listing or any commercial interest in JVs or manufacture/ trials or Stemprinter separation is damaging and none of these are covered by the description of R & D specified by KS. As you say this is the 'raison d'etre' of the company.
Unfortunately as many of us feared the rise today seems to have been mostly nullified by the damn Yanks.
I must say this BB is much more polite, positive and a happier place than ADVFN which I just looked at.. I don't think I'll bother again.
Spinnaker
Well Dodge
I think you are right. I have looked on those sites that offer margin trading and they say that somewhere between 70 and 80% of people lose money. Aim isn't that much different. Particularly with miners. I'll bet that most PIs lose money. We have been very fortunate with GGP. Hitting on one of the 1% good ones. Even when I spiked myself at 15.7p the SP recovered.
Of course we latecomers all wish we had put more money in at a lower start price. This definitely isn't transformational for me but very welcome. Many thanks to the serious posters here.
Spin