George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
Thanks Titiana
I agree with Schrow and Andym. A fascinating read.
Truly unbelievable that the supposed P3 trial results have not been released prior to EUA.
https://www.republicworld.com/india-news/general-news/what-is-virafin-dcgi-approved-drug-claims-91-percent-covid-patients-return-negative-in-7-days.html
Big 90% plus headline recovery but no publication of P3 nor any mention of trial size.
Seems to be administered by injection. Doesn't say whether I/M S/C or I/V
Further info will be interesting to see but no doubt the company will be churning out the numbers of vials right now. For India's sake, let's hope this does actually work without severe side effects but I have no idea how the dose levels compare with the WHO Interferon Beta trial which was negative for efficacy. Also the journalist who reported (in Titiana's post) thought it was ridiculous that the drug had been approved prior to publication of P3. The P2 was totally inadequate not only due to the small sample size, (less than half the size of SNG P2) but also because it was not blinded to the treating physician. Even India wouldn't have approved it based only that P2 trial. Also the P2 results were only published in April 21, some 5 months after the Lancet publication of SNG's P2 results. It does seem pretty amazing that 250 people for the P3 trial were recruited, dosed and results analysed so quickly.
All very strange.
Best to all
Spinnaker
Matterhorn
I also think I read something like that in the protocol. Ie it would be an algorithm or randomised but nevertheless if most of the patients are not very ill and they can't be given I/V or injections, the chances are that there won't be many people in the SNG trial who are displaying severe symptoms. I did think at the time when I read the protocol that they would have to either decide to either give a fair proportion of the severe patients the non-invasive treatments or equalise numbers on the trials. They obviously could not do both. In the former case the two non-invasive trials would fill up much more quickly than the others. This does not seem to be the case. Therefore I surmise that they are equalising numbers in each trial and this would automatically mean that a very high proportion of the cases treated with SNG001 would not be very ill.
Best Spin
Matterhorn and Matt
I don't think we are misinterpreting the doctors words but he may be misinterpreting the protocol as I implied below. The protocol did not have the intent to limit SNG to less serious patients but that may happen by means of misinterpretation of the protocol and/or the natural situation that seriously ill patients are sent to hospital for I/V treatment leaving only the not very ill for the Camostat pills and SNG.
Spin
Doc, re your 19.31 post.
What would be even better is if they put us into P3 in Activ-3 in parallel with upgrading to P3 in Activ-2.
That would definitely be positive for the SP.
Spinnaker
Great news from Kansas. Doc see 35 -38 mins. A very good question but Kansas was only able to give recruitment figures for that particular hospital. Slow take-up. 40 total for all 5? Activ-2 treatments and about half a dozen for SNG001. We don't know how many centres have SNG so it is difficult to extrapolate total take-up.
The protocol stated that I/V would be generally reserved for more serious patients and I suppose the corollary is that there will be more of the less serious cases for interferon. I am not sure this was the intention but the Kansas guy definitely said that the less serious cases were being used in the interferon trial. About six so far out of 40 in Kansas and he thought a few weeks to fill the 110 people for SNG and then to be assessed for suitability for P3 by external bodies inc FDA. Hopefully more hospitals will be recruited if and when we get into P3 (1000) patients.
It definitely seems that our treatment has been slower to fill than the Brii product. Also if only less serious patients are being treated with SNG it may well be that we will only get safety data and not much to help efficacy figures. This should not prevent progression to P3. I am sure Synairgen will ensure that the data from the home trial will be given to the Activ-2 trial administrators and there is certainly a possibility that the protocol for P3 will be changed in order to obtain statistically relevant figures.
Best to all investors
Spinnaker
Too right GKB. I have also been posting similar for months.
Prion, on your point about RM's expectation of 30% hospitalisation. That was way out wasn't it? I expected less than 10% and posted such, months ago. Given the Activ-2 entry criteria are wider, at least for the current P2, the hospitalisation rate may well be lower than for our home trial. This may explain why RM ignored Activ-2 in the briefing interview.
Spinnaker
There are some very genuine and sober posters on here paticularly Ghia , Harchris , Matt and Doc most of the time. I am not surprised Doc is frustrated. So am I. There are other posters like Oakleaf who remind me of the politicians on Question Time who trot out the same party line garbage irrespective of the question asked or the truth and call people names. One doesn't know if they actually believe what they say but suspects very strongly that they don't and are just saying it through habit or Pavlovian response.
We are mostly frustrated that SNG has not contributed to help prevent deaths in the UK over the winter. I expected a tie up with a big pharma after July and government assistance and then EUA EUA. RM stated the rate of progress was dramatic and this most certainly was the case between March and July but since then it appears to be back to the normal speed of pharmaceutical development and trials as though there was no pandemic.
Very concerning that RM did not mention Activ-2 in the interview. Also no progress on MAP, not even confirmation that one person has received the treatment, no indication of any product yet available and no offer of donation of product to India. No news on P3 progress other than a delay of three to six months and no news on Long Covid data from the home trial. Before anyone comes back, yes I do realise that an interview with Katy is not the place to give new news.
I suppose given all this and the fact that with present information there is now limited hope of approval in time for use next autumn/winter during the expected fourth wave it should be no surprise that the SP is floundering. What a crying shame.
Spinnaker
Thanks Matml
Obviously there is a hell of a lot of research going on in China at the moment and has been since the start of the pandemic. This paper comes from scientists all based in Guangzhou in Guangdong province.
The conclusion was about the only bit I could understand and it is clear that these guys think treatments and prophylactics are urgently required. and Interferon B should fit the bill. As we all know however, no matter the scientific evidence that SNG treatment has an excellent and widely accepted academic and in vitro research basis for efficacy, that is of no value in the regime of required human clinical trials that we are signed up to. There is no difference between a treatment that nobody has a clue why it might work and one with a logical theoretical scientific basis. The proof of the pudding is in the eating. The weight of evidence we already have leads us to consider that the chances of trial success should be very high but there is still a chance that the numbers won't be adequate to be statistically significant on any of the individual Phase 2 trials and only an amalgamation and meta analysis of all trials including both Phase 3s may be required.
The only thing that will enable authorisation in the west is successful and statistically relevant trial results. Unfortunately, most of us, are probably well down on our investment at current SP and the try line we are attacking does not appear to be getting much closer after multiple phases still retaining possession. The only thing that we still cling onto is the belief that the science is sound and we will score before the end of the game. If the game is refereed fairly we should emerge victorious but there are many tackles and possible turnovers still to come no doubt and we must never underestimate the oppo.
Sorry about my rugby metaphors.
Best
Spinnaker
Hi Matterhorn
I have written to Clinigen last year, I think, and they said they can't give me any info re any treatments requested or supplied under MAP and referred me to Synairgen. Synairgen referred me back to Clinigen as I recall and gave no information. As far as I was concerned MAP could have been a very good way to get visibility and at least anecdotal evidence of efficacy if not up to the standard of a formal trial.
This MAP status could have been utilised to save lives, produce additional data and provide promotion as a by-product and still can but no information has been released. The only feedback was from Kenneth who posted on here months ago about his father in Dundee but I don't think he got anywhere with either Clinigen and the doctor in charge of his father was more interested in promoting a local trial drug. That's not much info!
Even if SNG can only manufacture 10,000 this month and donated them to Delhi or wherever under compassionate use protocol I am sure Indian doctors would be very grateful and provide us with some data in return. The BoD do seem very blinkered and we have not been informed of any progress.
Unbelievably, Consilium were not prepared to release or possibly didn't even know the list of P3 trial countries when I asked them even though it had been reported by Synairgen to NIH and was in the public domain and posted on here immediately after my enquiry.
I am not sure there is enough oversight, carrot or stick being applied to our advisors, Consilium and Clinigen.
Spinnaker
That is a very interesting suggestion soonbetime. However I think that, politically, in the west, at least, your proposal would not be seen as P.C.. So long as we have the possibility of chasing the vaccine magic bullet that will be seen as preferable to rampant infection and treating those exhibiting breathing difficulties and at severe risk of serious disease. There is a possibility that the establishment view would change in the future if the vaccine effort was seen to be failing but certainly not at present.
Having said that, the UK is unusual in having a very high proportion of people willing to take up the vaccine and therefore although the current target market for SNG001 in Britain is small, this is not the case in many other parts of the world including much of the US and parts of Europe. I still feel that if we can get authorisation before the winter we will be able to sell the product in quantity.
I am still spitting blood that we have had no information released on MAP penetration and Clinigen may not have supplied the drug to anyone yet. Very poor show.
I am not sure of the cost price of the product but in exchange for a legal release and agreement to provide data it could be a great humanitarian and PR move to donate say 100,000 (or even 10,000) treatments to one or more Indian states for compassionate purposes right now. I certainly hope that some of our investment has been put to stockpiling the product, otherwise if and when we receive approval there won't be any fast roll-out. Also Scinv may have a valid point that without proof of ability to deliver in quantity short-term the US authorities would not countenance EUA. We would therefore have to wait possibly up to Christmas and publication and Peer Review of P3 hospital trials before any authorisation is granted.
Very disappointing at present not helped by the fact that sentiment is diabolical, general market has shifted to value stocks and SP going through the floor.
Best to all
Spinnaker
Another good thread with a broad range of views.
I didn't see the live conference but an abridged version. I don't remember hearing anything about the 30 and 90 day results. Can someone please tell me why these results have not been released, I saw mention in this thread about signing further patient acceptance forms. Do we have an indication of timing for release of this information please?
Very disappointing SP move on Friday and I am not totally sure that there will be a recovery next week. I do agree that there is negative sentiment partly due to delayed timing of P3 trial news enhanced by the UK excellent reduction and now stabilisation of rate of new infections despite the gradual lifting of lockdown. Surprisingly it looks at the moment as though things are proceeding as per government expectations and plans for a change. However infection rates in Germany and France are ten times ours so there will be plenty of scope for new variants which may upset the current status quo, particularly if travel restrictions are eased. Also the progression of Brazil and Sth Africa strains together with Indian strain potentially.
There is still all to play for but the Covid target market is smaller than we imagined back in July and there will be other drugs in competition by the time we get P3 results and (hopefully) subsequent approval. Like most on here I am depressed that despite all the company's efforts thousands have died who could potentially have been saved over the winter months and it no longer looks certain that we will have approval and mass manufacture by September in time for next winter.
Good luck all
Spinnaker
I can't see this cheap drug getting out there anytime soon without government money from somewhere to run approved trials. If it was found to work it could be a very cheap prophylactic for places like Brazil and India who don't have fast or deep vaccine coverage.
https://trialsitenews.com/germany-conservative-party-from-bavaria-promotes-ivermectin-for-e50m-clinical-trial-fund-targeting-covid-19/
Best
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