Member Info for spinnaker

I am very late seeing what has happened today. A bit surprised at the price reaction but not particularly surprised at the home results. RMs remark about needing a fire to put out may have been unscientific but turned out to be a correct analysis. Nevertheless the results are good not bad. I am pleased that they have sought to break down the trial population and re-analyse the hospital data for amalgamation. The decision to identify breathlessness as a pre-requisite for treatment is useful as a broad and simple criterion and helps to identify the population to treat and thus the likely market size and possible price bands to target. Population to treat now 11% of symptomatic infection of old people or others at risk with co-morbidities so only single figure percentage of those with symptomatic infection overall. If symptomatic infection is c50% of all infections that means a maximum of, say, 3% of current infections ie 3% of 2,500 in UK = 75 people per day would benefit from Synairgen's treatment. Very approximate figures so please let me know if I have my arithmetic wrong.

So firstly the target group for treatment is no longer almost infinite which could be a good thing since it will focus minds and possibly allow a higher price to be achieved for each treatment. It also emphasises that we should be looking for international roll-out in due course.

The thing that I am confused about is, why have they not included any 30 day and 90 day data in the statement released and why should it take until the summer when all that data has now been unblinded and should have been being analysed over the last couple of weeks since the 90 days was up?

I thought the time frame for release of the initial data had now passed and the reason we were waiting was to incorporate the 90 day data in the same release. That is why I had suggested 24 May plus or minus two weeks. Apologies I got that wrong. This long data has not been included and so now we are awaiting the 90 day data which I would expect they should have within the next three to four weeks and not have to wait until the summer. This is unlikely to be earth shattering data and may not have much impact on the SP either plus or minus but will still be useful information for the future.

Best to all

Spinnaker

Interesting points chaps. My expectation was that the route would be open for an application for EUA after roll on to Activ-2 P3 from P2. That was what was said by the Chicago trial group on video months ago. However the date of issue of any EUA seems unlikely to be before adequate trial data has been unblinded. I suppose it is possible that the data could be known only to a small panel running the trial and another panel at the FDA or relevant authority granting authorisation
Does anyone know what the sequence for the mAbs approvals was that have already been granted EUA from earlier Activ-2 trials?

Spinnaker

Thanks to all contributors in this thread, especially Scinv for being so open and describing his thoughts as to how the trials should have been set up and criticisms of SNG BoD in a calm and understandable way. Also Ghia in addressing all the points in an adult way. All posters have made very valid points.

Doc and Ghia are right though that although it would have given even better results, and a tightly defined target market for an expensive and very effective drug, if we had fully screened patients before accepting onto the trial and had much stricter criteria (such as existence of auto antibodies to type 1 Interferon) we certainly wouldn't have filled the home arm yet and it would have increased the time needed to fill all the trials. With Activ-2 taking detailed information and presumably blood and saliva and naso/pharyngeal samples for each patient this could prove of huge import for effective targeting down the line.

It is Sod's Law' that each country at a particular time is either totally overwhelmed by the number of ill people or else there is inadequate infection given the proliferation of trials to fill each trial in a reasonable time frame. This will probably be a difficulty with P3 resulting in a fairly long time frame.

I agree that screening will be regarded as important and a lot of development is probably already underway. I would love to think you could just load a blood sample into a machine and the computer attached with full diagnostic A.I. would give a read-out of all relevant levels of each blood constituent and parameters and spew out the recommended treatment regime.
This would enable a more holistic and patient specific approach. Unfortunately, I expect this is quite a few years away. When was Star Trek set?

I think the reason I am slightly jittery is that I am highly exposed and wish I had been a little more risk averse and sold down a bit when it was over 170p. At current SP level I am disinclined to sell and actually bought a few more to potentially trade over the next few weeks if the Home Trial results don't come before my target date of 24 May.

Having said that I remember when Woody said on I think 10 July he had sold down to de-risk having read Nolupus's comments just a couple of weeks before Magic Monday. It does feel a bit like 'deja vu'. Bear in mind though, we are at 140p a share instead of 35p.

Good luck to all investors and let's all hope that Synairgen can assist in this current pandemic, not just the next one.

Spinnaker

Thanks Deanok

Obviously a computer glitch. I think it relates to the SP a week or so ago and the rise on that day. Just stuck there.

Best wishes.

Spinnaker

Has anyone any idea why Vox is showing WSBN up 14% at 14p?
Thanks
Spinnaker

Stu

Surely RM had no inside knowledge as to the date Activ-2 results would be revealed. There are many factors that would affect the timing including the unknowns of patient take-up, infection rate, testing speed status and importantly the number of drug products on Activ-2 at the time. All these drugs would be in competition with SNG001 for the limited number of patients recruited. Until we have been informed that the target number have been recruited, any estimate of date for results can only be an informed guess.

Spinnaker

Thanks for that Matt. We won't be changing the trial design any time soon.

Spinnaker

Matml. Thanks for that link. I haven't read it all but it sounds as though SNG001 may be even more effective via nasal inhalation rather than through the mouth.

I have rather assumed that at present the nebuliser used gives access to the lungs through the mouth to trachea rather than the nasal passages. That may not be correct though. Can anyone confirm? Also, if it is through the mouth can a patient still exhale through the nose, thus allowing some interferon to access nasal mucosa?

I am interested if anyone has knowledge on this topic.

Many thanks

Spinnaker

Scinv

Thanks for your response. I didn't say that all I saw was arrogance in your posts at all.

I too have thought for ages that all patients should be screened on first testing positive for things like genetic mutation causing poor interferon production and auto antibodies to INFs.

We aren't there yet but our trials may encourage progress along that route and better match treatment to individual frailties.

Spinnaker

I think this is an interesting thread and do respect Scinv's postings. Having said that they can be difficult to follow and, Scinv, you do sometimes adopt a tone that infers that everybody whodoesn't see the problems as clearly as you is, by definition, a moron. This tone can sometimes alienate other board posters and holders.

I would like to ask you a question having read all the posts. I understand your conclusion that selecting only people with low interferon levels or with autoantibodies to interferons would give greater confidence levels of a statistically relevant outcome for every trial. My query is, do we know whether the P2 at home trial or the P3 international is testing patients for these adverse signs before dosing? It seems to me that if we have this information it would be helpful. However I also understand that even if we have these figures, those numbers may be 10% or less of the total trial numbers and therefore reduce the statistical significance of the results for that specific cohort .

Secondly you seem to think that the Activ-2 trial will not only definitely test for personal defects prior to inclusion but even, on the P3 element select trial participants on this basis. The protocol hasn't been issued for P3 yet so we will have to see but I assume your thinking is that the Activ-2 P2 results will show that recipients with the defects noted will respond more favourably to SNG treatment than others and therefore the trial organisers will try and select those specific defective patients for our treatment based on these criteria. (Ie presence of auto antibodies against INF and /or low INF levels.

Is that correct?

Many thanks

Spinnaker

Sorry; forgot the link. Courtesy of Iveyspivey on another BB.

https://www.cnbc.com/2021/04/22/new-covid-variant-detected-at-texas-am-lab-shows-signs-of-antibody-resistance-and-more-severe-illness-in-young-people.html?utm_term=Autofeed&utm_medium=Social&utm_content=Main&utm_source=Twitter#Echobox=1619106327

There are loads of them around now all over the world. Not good news for the economies or lives. Synairgen 1 is needed asap.

Talking of that, I have been incensed that we have allowed tens of thousands of people to come into Heathrow from Delhi for the last three months, just like the flights from Wuhan in Jan to March 2020. Waiting for proof of VOR before taking action is like waiting for proof that smoking causes cancer or asbestos causes asbestosis. Lots more people die in the meantime!

Spinnaker

Doc, I think you are right re naming.

I vote for Synairgen 1, like Thunderbird 1 Simple and memorable.

Spin

F&V, Doc and Seaboy, ScInv etc. Thanks and Interesting responses.

Yes of course R&D etc needs to be reflected in pricing but the percentage of sales price that repays the risk and R&D is very much a factor of volume x longevity of sales and of course pricing affects the volume so there are various ways to skin a cat. I am sure there are pricing conventions amongst drug companies but I am just looking at it from a logical point of view. If say we had a contribution towards costs of £200 per treatment out of the sale price and sold 100,000 treatments per annum that would repay the say £200m (£100m doubled for risk) development costs in 10 years but if we sold 100,000 treatments per month (RM's 2021 target) all £200m would be recouped in less than one year. I certainly hope that the UK won't have that many patients meeting high risk criteria this year. USA and India probably will though.
Our drug, if approved will hopefully not have a short life expectancy since it's use for high risk patients will be ongoing in respect of various respiratory viral infections subject to further successful trials.

Very interesting list of average development costs per drug F&V. It is clear from that, that any approved drug that is widely required will give a value of £2b plus to the company. So much better value to buy the company or rights without all that time and risk capital.

Best Wishes to all.

Spinnaker

Thanks Seaboy for your great work. There are a few others in the frame including the AZ and GSK and Camostat in the Activ-2 with us.

I agree with you Doc that the level of competition, say, if and when we are able to make an application for EUA may well affect the likely pricing. Does anyone know if a proposed pricing menu would need to be given as part of the EUA application? If not that would mean we could keep powder dry for a bit longer but the lack of cost information would certainly discourage Horby and UK govt. from making any early approaches for pre-orders. I guess Boris is hoping to get something sub £500 from the new anti-viral pill campaign and ideally sub £10 like Ivermectin. The time frame laid down by Boris and the expected cost limits on NHS procurement of two drugs for standard of care mean that these have to be repurposed drugs or if new drugs, already well down the road in trials as is SNG001.

I have no idea of the potential pricing of Camostat for instance but pills are usually at the cheaper end of the spectrum and take little time or set up costs to administer.. New drugs will always be more expensive than repurposed drugs though particularly if out of patent and generic. The initiative may come to nought of course. There are circumstances where £2000 would be a very good deal (if it prevented a patient needing hospitalisation and oxygen and long Covid) but this is fairly difficult to target currently. At present the NHS doesn't seem to be set up with simple procedures, ie A.I. programmed blood tests to determine markers for severe disease progression such as low interferon levels and/or genetic disposition as soon as a positive test has been made. I think we are not expecting SNG to become widespread standard treatment without such testing. I.E. we are thinking along the lines of 'Standard of Care' for obviously high risk patients only ( eg very old with co-morbidities) as the best case scenario, this year at least.

I would expect with large orders the company could make adequate margin and profits at a price to UK govt. somewhere between £400 and sub £1,000 per treatment at a guess. At these price levels even if only one out of four were saved from hospitalisation it would seem a good deal to me for UK plc.

All the best

Spinnaker

I haven't a clue what that means but it's stated in the 19 April RNS.
It doesn't sound very scientific and I really don't know why I invested in this company, now regretting it despite buying the masks.
Good luck all.
Spinnaker

Apologies for potentially misleading statement below. The I/V treatment is a single dose but monitored over 14 days.

Spin

Thanks for that Agent B. I did see it when it was published on 10 March but I don't know if the EUA application has been made for VIR 7831 . It will be all over the press if approved so I don't think that has happened yet.

The ICE trial of VIR 7831 is the treatment that GSK are appliying for EUA. This is a 14 day I/V programme so not as accessible as SNG001. Trials are ongoing for I/M injection treatment with the same drug which mode of treatment would be more comparable to SNG.

Camostat tablets are on Activ-2 and would certainly be a popular political option if trials are good.

The big plus for an inhaled treatment, as many posters have said is that the dosages required should be less as it is targeted to the lungs and therefore concerns of unwanted side effects should be less. In principle targeted techniques are increasingly preferred in cancer etc as also stated on another thread.

Still looking good for us despite the longer than hoped for time frames.

Good luck all. Spinnaker

I agree with Poised. It is a very good question; whether a false positive could be repeatedly be generated by the same person even when they weren't infected. In any event with two positive results I wouldn't want them mixing in the community. From a public health perspective the incidence of false negatives is surely more concerning for people arriving in the country. A second test after 5 days carried out by a health professional should be mandatory since they could have become infected on the plane or in the airport.

Also, I agree with jdt1990 that a negative PCR test 72 hours before flying is not adequate. Michael Mina's graphs show infectivity within 48 hours of infection.

If we are going to allow increased plane travel it will also be important from the track and trace point of view that airports do not allow mixing of passengers from different inbound flights which will be a serious management issue to resolve and does not seem to have been attempted as yet.

Looking good for Avacta though. Very positive vibes.

Spinnaker

I must say, looking at the link below I find it beyond amazing that the govt. seems to be waiting until the Indian strain is proved to be a 'Variant of Concern' before stopping flights from Delhi etc. It is totally nuts. The cost of any potential variant evading our vaccines would be huge both economically and from a public health viewpoint. We should be doing it the other way round. Shoot first and ask questions later. As an island we are able to protect our borders far better than most countries and should have done so previously and should do so now.

Spinnaker