Member Info for spinnaker

Nasdaq price still 30p per share below London.

I sold half my holding in TILS just now at near break even and was planning to buy TLSA through II. I phoned them and they told me they are no longer allowing purchases of TLSA, only sales.

Does anyone have a recommendation of a platform to buy TLSA shares since neither Barclays nor H/L will deal in them.

Thanks

Spinnaker

I am sure this is a brilliant appointment for the company. It certainly needs some heavy hitters, not only on the development side but also the monetisation element.

The next appointment will hopefully be in Investor relations!

Spinnaker

Bella

I responded to your post late yesterday but will have got lost in the rush following the excellent news today both here re P3 start and in US.

I felt slightly strange listening to the story of the mum in Hull who has just been dosed. It seemed to pass by the BBC that this was a trail and there was a 50% chance of her receiving placebo!

If we get BBC exposure increasing then that could drive take up of MAP.

re-posted below:-

Bella
My view is that at present almost no doctor in most of the UK has any time to read emails let alone professional publications. Their noses are to the grindstone and they are not coming up for breath that often.

I corresponded with Clinigen and they told me that they had no authority to publicise the MAP authorisation so most probably a large percentage of front line medics don't even know about SNG001 let alone the MAP situation. I would suggest that paper and article will have almost no effect on the visibility of the treatment. EUA and subsequently being adopted as standard care by US or UK would obviously be transformational though.

Has anyone asked Synairgen how many MAP applications or authorisations there have been so far? Clinigen wouldn't tell me and I haven't ever corresponded with anyone at Synairgen and I don't suppose they would answer an unknown investor right now.

Spinnaker

Bella
My view is that at present almost no doctor in most of the UK has any time to read emails let alone professional publications. Their noses are to the grindstone and they are not coming up for breath that often.

I corresponded with Clinigen and they told me that they had no authority to publicise the MAP authorisation so most probably a large percentage of front line medics don't even know about SNG001 let alone the MAP situation. I would suggest that paper and article will have almost no effect on the visibility of the treatment. EUA and subsequently being adopted as standard care by US or UK would obviously be transformational though.

Has anyone asked Synairgen how many MAP applications or authorisations there have been so far? Clinigen wouldn't tell me and I haven't ever corresponded with anyone at Synairgen and I don't suppose they would answer an unknown investor right now.

Spinnaker

Kenneth

This is the link to the Lancet Peer Review of P2 trial. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext
Good luck.
Spin

Doc. That is funny!
Spin

Titania
I don't have persoal experience but pretty sure I read under the MAP protocol that the drug would be provided free of charge by the supplying company, ie Synairgen. My questions to Clinigen produced only a polite brush off and I haven't written to Consillium or Synairgen. You could though.
Best wishes

Spinnaker

LSE closing 12.30 tomorrow so trial first dose notification this year at last chance saloon.
https://www.londonstockexchange.com/trade/trading-access/business-days.

What do other people think? I am concerned that the number needing hospital care is going to go through the roof in January and I am just not sure there will be time availability for medical staff to go through the procedures necessary to enrol patients on all the trials currently in operation. Our P3 trial requires a lot of information to be submitted and I wonder if some of the NHS experienced members can input. In overload mode are our hospitals and those in US going to be able to run the trial effectively? If not then this will undoubtedly delay the trial filling and concluding. Are we likely to get any preliminary data before the end of February?

Many thanks

Spinnaker

Thanks for that number crunching Dudio. Very helpful and I don't disagree with your conclusions.

Spin

I posted a couple of days ago a copy of a letter I wrote to my MP . A couple of respondents not hopeful that it would even be read. It obviously was.

The purpose was to bring the 'At Home' trial to her attention and point out that due to previous lack of interest by the government it was quite likely that SNG001 progress from here would be Stateside. She has responded quite positively and I have pasted her reply below.

Best wishes to all SNG supporters

Spinnaker

Dear David,

Thank you for your recent email concerning this possible treatment for Covid 19 and clinical trial.

I am very grateful to you for drawing your views to my attention. However, my ability to influence such situations is limited, but I will be happy to support you where I can.

I have made representations to NHS England on your behalf, to ensure they are aware of your points, and I will write to you again once I have received a response.

Best wishes

Nus

Nusrat Ghani MP
Member of Parliament for Wealden
House of Commons, London SW1A 0AA | 020 7219 4619
Twitter: @Nus_Ghani | Facebook: NusGhaniMP | Instagram: @nus_ghani | Website: www.nusghani.org.uk

Sorry, the lady's name is Julie Gosper not Godber.
I find it odd that no update has been given on the MAP situation and wonder whether it just hasn't been able to be accessed by anyone yet.

Spinnaker

I have received an email from Julie Godber at Clinigen.

Only one of my questions was answered and she confirmed that Clinigen is not able to promote the availability of SNG001 under MAP . Text attached below. Would promoting awareness be the job of Consillium or directly down to Synairgen?

Spinnaker

Thank you for your enquiry and well wishes. Due to both the nature of the access programme we have put in place with Synairgen and the license status of Synairgen’s product, we are not permitted to actively promote the product or provide information to external parties about the product on behalf of Synairgen which might or might not be price sensitive.

We thank you for your understanding,
Best wishes to you for the festive season,

Kind regards,
Julie

It is interesting to note that counter to what was stated on TV the other day that all natural mutations occur during replication of the virus and therefore are not occasioned by the act of transmission from one host to another. Long lived infection and suitable conditions is the hotbed of replication and therefore mutation.
Spinnaker

Just an update Elsol. I have two auto responses one saying the person is on holiday and the second that they will get back to me today. I expect little or no information will be forthcoming on grounds of client confidentiality and perhaps the questions would be better asked of Synairgen or Consillium. I will await further response.

Spinnaker

Good post Dafad. Thanks.

This shows the competition Synairgen will have in getting traction. I guess the 6 Synairgen patients were dosed as part of the P2 trials in May/June. Obviously the Home Trial will not be part of Notts Hosp. treatments.

Hopefully the fast track P3 trial will be able to oust some of the other less effective and perhaps some P2 trials but Recovery has top spot at present and this may continue. Very interesting statement that 50% of patients refuse to join a trial.

This is an area where government and main news broadcasters can be very important in shifting public opinion and would enable faster fill-up of all trial places that are available at all hospitals.

Spinnaker

Thanks Doc

I have written to her before and mentioned the 79% so this was more of an update and a prompt. I'm no good at Twitter, well I'm not going to try it. Also no good at Sun headlines.

No doubt you and others have done a lot to promote. I must say it is unbelievable that the 'At Home' trial hasn't filled after so many months . Have also written to Clinigen and asked for progress report on MAP roll-out. Maybe there is no budget for promoting that since I believe one of the requirements is the drug is supplied free of charge and the extra costs of promotion not thought worthwhile for the level of likely publicity. I am surprised about that too.

I'm not a doctor but you might know if these two options have been advertised or promoted in the professional press.

Thanks

Spin

Thank you for that vote of confidence Parsley. The point was really that there is direct contact between MPs and their constituents and in the absence of the government wanting to promote 'At Home' trial and Synairgen seemingly without the budget or inclination individual MPs may be interested enough in their electors to notify them.

Spinnaker

It is marvellous news that various vaccines are looking very positive and the Pfizer vaccine is already being rolled out. However the government’s concentration on PPE, Test, Track and Trace and vaccine development have put life saving treatments on a lower rung of the ladder up to now. However the mass dosing with vaccines will not prevent some people becoming very ill and it is unfortunate for the country that the government and other agencies have not taken any active part as yet in enabling the filling of the at home trials for SNG001 or until recently in Phase 3 trial progression. Fortunately the FDA in the USA have now taken a very close interest in the international Phase 3 trials about to start (see paste below) and will undoubtedly expedite the process with some possibility of an early authorisation if interim results are anywhere near as good as the previous Phase 2 trial. It would be unfortunate if this world leading British designed treatment was not collared and owned by the UK government and instead by default the US managed to take the lead in using it to save lives during the pandemic.

I have copied and pasted part of the 18 Dec 2020 RNS from the company Synairgen below.

Many thanks for your assiduous attention to everyone in Wealden and I hope you enjoy the ‘little’ Christmas we will all be having.

Happy Christmas

Kind regards

I get fairly regular emails from my MP and each MP must have emails for thousands of their constituents so just an idea but I have sent this email to my MP. Anyone is welcome to use it as a basis for their own email. Be aware you must be an elector in the Constituency and give your name and address on the email or it will be ignored.

All the best.

Spinnaker

Dear Nus

You may already be aware but for all over 60s and over 50s with certain underlying health conditions who get infected with Covid there is a home trial ongoing using SNG001 nebulised interferon treatment which has been shown to have high efficacy. https://www.covidtrialathome.com/

I note that you have included a list of useful numbers in your recent email and It would be helpful to all Wealden residents that they were aware of this trial since it has not been adequately publicised and some places are still available despite the mass infection levels currently experienced. If anyone does not have access to a computer then there is a phone number 0330 133 2870 (9am - 5pm, Mon - Fri). Application must be made within I think 5 days of first symptoms or positive test but ideally the earlier the better. The treatment is intended to reduce the likelihood of exacerbation, the need for hospitalisation and or oxygen and targets the lungs directly. It is thought that by stimulating the body’s initial natural immune system there would also be a likely reduction in ‘long Covid’ and this is an additional area that will be included in the new P3 trial.

If anyone is worried that they may be selected for the placebo arm as opposed to the real treatment then the MHRA have agreed access under MAP to patients who wish to have the treatment where agreed by a competent doctor in charge of their care. Access to this is through Clinigen Ltd but no doubt further details are available through the above number.

You will obviously want to check out what I have stated and once you have done so I am sure that you will ensure all your electorate are aware of this very useful treatment and trial which has the potential to save many lives.

It is marvellous news that various vaccines are looking very positive and the Pfizer vaccine is already being rolled out. However the government’s concentration on PPE, Test, Track and Trace and vaccine development have put life saving treatments on a lower rung of the ladder up to now. However the mass dosing with vaccines will not prevent some people becoming very ill and it is unfortunate for the country that the government and other agencies have not taken any active part as yet in enabling the filling of the at home trials for SNG001 or until recently in Phase 3 trial progression. Fortunately the FDA in the USA have now taken a very close interest in the international Phase 3 trials about to start (see paste below) and will undoubtedly expedite the process with some possibility of an early authorisation if interim results are anywhere near

I have just sent an email to three addresses at Clinigen as below and will let you know the response.

Dear Julie

Thank you for your email below. I note that we have had a massive resurgence of Covid in the UK and it is obviously causing huge disruption. Worse than that, the hospital beds are now very full with sick patients. Although you have many clients it could be that Synairgen is currently one of the most important.

Given that the SNG001 treatment has not yet been given full authorisation it seems the very important ball is now in Clinigen’s court to enable as widespread use and as many lives saved as possible.

I would be grateful if you could please answer the following questions for me.

1) What marketing and promotion in relation to the availability of SNG001 treatment under MAP have you carried out and what limitations are there within relevant Codes of Practice or professional guidelines? If none carried out, is this due to restrictions in your remit from Synairgen?

2) How many treatment courses have been applied for and how many responsible doctors does this involve and in which countries?

3) How many treatment courses have now been authorised and distributed under MAP and in which countries?

4) What are your targets or anticipation for treatment course distribution to patients within the next three months and to which countries?

5) Are you responsible for collating/monitoring progress in patients and outcomes so that data can be useful prior to P3 Trial readouts? If not who is?

I look forward to receiving your response as a shareholder in both Clinigen and Synairgen.

Many thanks

Kind regards and best wishes for Christmas.

From: Julie Gosper [mailto:Julie.Gosper@clinigengroup.com]