Member Info for spinnaker

Thanks for that post and link Johnny.

I see this was a tiny trial of critically ill patients based on licence on compassionate use grounds. The tablets performed better than hydroxchloroquine. I saw reference to another larger trial and will try and check that out.

Spinnaker

A really good thread. Thanks to all participants, particularly Matterhorn for starting with the facts.

Spinnaker

https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(21)00048-7/fulltext

The above is a link to an Ebiome/Lancet paper dated 3 March 2021 on the only other non I/V treatment currently in Activ 2 with SNG001. Janet Wood**** and others have postulated that the Holy Grail for Cov19 early treatment would be a tablet. This is a tablet , two doses per day for five days postulated. It is far too scientific for me to postulate an opinion or explanation but others may have a view. I should note that this paper appears to bear no relation to Sagent who I believe are the sponsors for the drug in Activ2 trials.

I don't know if there have been any human trials yet but this publication appears to be only related to ex-vivo studies so presumably does not have the evidence of efficacy that SNG001 has to date.

This may already have been posted here in which case, my apologies. Also there may be other in-vivo studies which I haven't seen.

I would expect that inhaled treatment would be preferred to I/V or Intramuscular injection for pre hospital treatment and there must be concerns that mAbs are sensitive to variation of the virus. At my basic level of understanding therefore I would think that SNG would be readily taken to P3 and EUA if efficacy is shown. Also and importantly it should be a popular method of treatment including pre-hospitalisation.

Spinnaker

Old Apache

You should not that the vaccine does not reduce infection of the recipient until after 14 days and takes from 14 to 21 days to full effectiveness. I do feel bad for your accountant and hope they recover but it is most improbable that the vaccine caused Cov-19. It is quite possible however that their attendance at the vaccine centre was the reason for the infection, particularly if that was the first time they had been out of the house in the past few months as most 80 year old's I know.

Best wishes to your accountant for a speedy recovery.

Spinnaker

This may have been posted before but I haven't seen it.

Apparently since March 2020 Interferon Alpha 2 has been approved for use in all Covid patients.

A record of outcomes published 20 September 2020 stated that the treatment was helpful but the wide age disparity in the main group treated with interferon to the control group (much older) who refused the interferon must mean that the analysis was not straightforward. It looks like the treatment was intra-muscular injection.

Spinnaker

https://www.liebertpub.com/doi/full/10.1089/jir.2020.0124

Tommy. Thanks for that. I take your point but so far the info published has been timely.

Spinnaker

Doc. - I agree with your sentiments absolutely. For people to suggest you are de-ramping or are ascribing minimal value to SNG now is blatantly ridiculous.

Back in July when we had the P2 results there was no vaccine likely to be delivered by the end of the year. There were no useful approved treatments and, in a way Synairgen could have been thought of as a world saviour. I certainly described it to my G.P. nephew as a potential game changer.

Things haven't panned out as I had hoped and we have had an extra 60,000 deaths or whatever since then. SNG is not in the hospitals yet and there are still no approved early stage treatments. This alone is a failure of our current system probably due partly to the concentration of money and effort on vaccines by not only the government but also the big Pharmas. Now there are a number of potential treatments in process and about seven approved vaccines internationally. The playing field has not remained unchanged. This does not mean there is no longer a rainbow for Synairgen but it is undoubtedly a less distinct rainbow and possibly only visible from certain places on the globe. A pot of gold is still a pot of gold though.

I have not sold any of my holding since I still believe SNG001 will eventually come to play a major role not only in Covid but probably 'flu' and other pulmonary viral infections including possible pandemics in years to come. I will also be proud,if this turns out to be the case, that my investment into the share offer in a small way assisted Synairgen to progress P3 trials and subsequently bring the product to market.

Spinnaker

Hi Rum (a man after my own heart judging by your name). I'm not intending to be combative just getting increasingly pedantic in my dotage. I do understand your light heartedness. I just can't stand people thinking that 'of' is part of a verb or denotes any of the past tenses. By the way your proposed contractions are perfectly proper English. Yes you are correct that -'ve -has been converted by some people to -of- instead of -have-.

My last post question was about the substantive point I raised, not the use of English. I have just checked and although my internet skills are not that great I cannot find a version 4 of the Activ 2 protocol. If that has not been finalised or published there is no P3 protocol for SNG001 to progress to. Therefore the best that could happen as and when the P2 was completed, or otherwise ready to roll on to P3, would be for the programme to pause. Not an ideal scenario. My point was that that is unlikely and therefore Graham's proposition also unlikely.

Check out p67 https://fnih.org/sites/default/files/final/pdf/Protocol-activ-2-A5401-version3-dated12.22.20.pdf

I think that document is v3 of the protocol dated 22 Dec 2020 and we are waiting for the protocol for P3 for the 2 non-infused drugs currently in the trial, one of which is SNG001.

Best wishes to all

Spinnaker

And to the substantive point?

Graham

What you suggest is unlikely since they haven't released the revised protocol for P3 non I/V drugs yet unless I have missed it. Also please write English. They wouldn't OF discussed anything . They may HAVE discussed something.

Well done Rupert
You got it out there with good revisions.

It's interesting that a few of the specialists at Stanford are keen on interferons in general and Synairgen in particular. Certainly Active 2 is vital and I expect USA is now our prime target market.

Doc

I think you are trying to rein in expectations quite understandably but after listening to a couple of interviews of Janet Wood**** the boss of the FDA she is concerned that although the approved mAbs are available on the shelves in the hospitals they are sitting there unused. It appears that the doctors are not keen and I am sure it is not cost. Probably more difficulty in setting up I/V etc.

Spinnaker

Sorry link omitted
https://www.frontiersin.org/articles/10.3389/fphar.2020.592543/full

Org
This is a paper from the Amiens-Picardie hospital referred to by Synairgen staff member. From a brief scan they only treated 4 patients with interferon.

It is not the same as the P2 or P3 study in Bordeaux where they are using thre or four drug options on 6 or 800 patients from memory. Sorry I don't have the link but it is in one of my previous posts. Both inhaled interferons.

Spinnaker

Not really surprising. The hospital patient trial for convalescent plasma was stopped a month or so ago due to lack of efficacy.

Spinnaker.

It sounds very sensible and I doubt it will cost £2000 a bottle.
Spinnaker

All the chat has been on the sale price of our treatment and not much on the cost. Projected sales prices suggested have been from £200 to £3,000, Everyone seems to expect an 85% GP but this is obviously impossible at both these figures.

I have no idea of the cost to Synairgen of the SNG001 doses but it will depend on quantum and supply chain. If say it was £10 per dose x 14 and the nebuliser was £10 then the cost of 14 doses would be £150. A sale price of £3,000 would therefore give a a GP of 95% and at a sale price of £200 the GP would be would be 25% so a very big difference. Say fixed costs inc depreciation and head office but excluding tax was say £50 per treatment. Then assuming 500,000 treatments by next December. NB this is less than the 100,000 pm mooted by RM but no indication how many treatments are yet ready to roll and he has appeared to back track on this number, and does not include supply to USA which I expect would be manufactured in that country.

Total cost as above say at £200 per treatment x 500,000 =£100m
T/O at £200 per treatment x 500,000 = £100m therefore profit =£0
T/O at £3,000 per treatment x 500,000 = £1,500m therefore profit = £1,400m
This is projected to end of 2021.

So quite a big difference between these two figures.

Does anyone have any insight as to the actual likely costs of production?

Best to all

Spinnaker

I agree Org. Caution is necessary. I don't think there was any direct mention of Synairgen by the French Health minister unless anyone has a link. It may just be the journalist making an assumption.

I thought it had been pretty much agreed on this board over the weekend that the reference was probably to the InfB1b made by Extavia being trialed in Bordeaux that Olivier Véran was referring to. https://clinicaltrials.gov/ct2/show/NCT04356495?term=interferon&recrs=a&cond=Covid19&cntry=FR&draw=2&rank=5

Never mind, this is a fairly small trial c 200 but may be labelled as P3 for at home treatment. It certainly won't rush to universal worldwide acceptance but will increase visibility of interferon treatment if trials positive. Also there may be some discussions to be had re. Synairgens patent protection. I am not sure on that one. Also the trail end date is stated as Aug 2021.

So, all to play for and I expect a large market for effective early acting therapeutics over a long time period.

Spinnaker

I agree Org. Caution is necessary. I don't think there was any direct mention of Synairgen by the French Health minister unless anyone has a link. It may just be the journalist making an assumption.

I thought it had been pretty much agreed on this board over the weekend that the reference was probably to the InfB1b made by Extavia being trialed in Bordeaux that Olivier Véran was referring to. https://clinicaltrials.gov/ct2/show/NCT04356495?term=interferon&recrs=a&cond=Covid19&cntry=FR&draw=2&rank=5

Never mind, this is a fairly small trial c 200 but may be labelled as P3 for at home treatment. It certainly won't rush to universal worldwide acceptance but will increase visibility of interferon treatment if trials positive. Also there may be some discussions to be had re. Synairgens patent protection. I am not sure on that one. Also the trail end date is stated as Aug 2021.

So, all to play for and I expect a large market for effective early acting therapeutics over a long time period.

Spinnaker

I obviously wasn't the only one that thought the UK Gov't would either fund an urgent P3 or the MHRA would immediately issue EUA following 20 July results. Alternatively I fully expected a J/V with an American pharma to progress further trials and manufacture. First the collation of results and analysis took a long time and then submission to The Lancet for peer review was delayed. Eventually, a decision was made by the company to go it alone and raise cash for a self funded P3. It was clear by then that SNG001 would not be able to save any of the ill people this winter. It may well be that RM's thoughts on price and value prevented any of these options but I don't think this was the only reason. The failure of the company to publicise the home trial was ridiculous and the apparent difficulty in accessing MAP is another very upsetting failure.

As I understand it the UK gov't puts a value per life saved at somewhere between £100,000 and £300,000. Perhaps less for old people. If the extra deaths over winter could have been reduced from c 80,000 to 40,000 and hospitalisation halved, in hindsight we may have been able to get through the winter with much lesser restrictions, government spending and damage to the economy. Decisions could have been made by September by MHRA given that everyone knew by then that the winter was going to be dire. Very depressing thinking about this and what might have been.

It is a real saviour that the vaccines have delivered so quickly but as we all know there will be a continuing problem and further exacerbation next autumn as soon as everyone gets back from holidays and schools and unis go back. This will be worse if variants make the current vaccines less effective. The summer is going to be a busy period for the scientists tweaking the vaccines and re-vaccination will be like painting the Forth Bridge.

Let's all hope that SNG not only flies through the current trials but is able to be made available in volume and at a reasonable price to save lives later this year. Also I am hopeful there will be other treatments, maybe other interferon treatments available to keep people out of intensive care. I am not that hopeful the mAbs will be the answer because they are so specific and most require I/V treatment. They are still unused on shelves in US hospitals according to Janet Woodman.

Good luck to all and keep safe.

Spinnaker

Sensationalism is perfectly proper word to describe 50% or more of the newspaper output in my view. It's a shame the BBC is moving more towards this model as well.

Spinnaker