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1 week ago now, not long to wait for Activ 2 results, perhaps as soon as next week!
I’m sure in any review the teams will adjust their expectations in line with the protocol. The bar will undoubtedly be lower and we know from our own study that even in that situation we showed a threefold improvement in a sub group of that population
Just saw Bryosa's extract.
Please substitute 'lower risk of progression' for my 'not very ill' and vice versa.
Thanks Spin
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
ACTIV-2 protocol summary says, “ The study includes both infused and non-infused agents. For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19”
Matterhorn, Yes I was sure I read in the protocol that an algorithm selects the drug.
Don't get too hung up on efficacy in P2 of Activ-2. The drug will show safety and in all likelihood will reduce viral loads and that should be enough to get it through to P3. 200 patients is not enough to show efficacy for any drug on a measure of hospitalisation/death with the cohort being investigated. P3 is going to recruit 1000 patients which will give the drug a chance to show efficacy even in milder cases. Those patients are going to take around 12 months to recruit unless the trial rolls out on a large scale internationally or the US experiences another severe wave. The hospital P3 will be done and dusted by then and the drug should have full approval if data comes up as expected.
Activ 2 (operation warp speed) P2/P3 progression may still provide the opportunity for early EUA however, but does not seem to have the same significance that it has in depths of last winter.
4 out of 5 most vaccinated countries are seeing increases in coronavirus cases. Source Forbes.
Off topic but I wish Oak and Doc, would shake hands.
mattw007 - I should’ve added context to what I meant. My reasoning is that they have higher hopes for SNG001 to be safe and potentially efficacious in lower risk people.
I do agree with you that should SNG001 is be removed due no benefit in lower risk people then it’d be ridiculous.
Spin - I interpreted his words in the context of what the protocol states as I knew we were not just for lower risk patients. But, of course it’s possible that in practice the higher risk are ‘naturally’ given to I/V if that decision is left to a human.
However, isn’t it an algorithm which decides who gets which agent?
Last word syndrome. Watch
Doc, Cheers for the advice but why would I not laugh at your posts? Have I Got News For You is only on once a week.
Doc, it might be best to filter Oak as I now have. We don't want the board taken over by a personal spat.
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
Doc, I don't pretend to know much about science, investing or the commercial world but I can spot a bad person a mile away. It always came easy to me that. Even got told off on Redditt for calling one out.
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
Doc, you constantly talk nonsense designed (in many ways) to confuse. SP is where it is and your job is done. Move on ffs
Doc - why on earth would you want SNG001 to be removed from ACTIV-2 which would kill off a potentially huge market for Synairgen especially since it may potentially be the or one of the best therapeutics to prevent people from being hospitalised in the first place. SNG001 will never be added to ACTIV-3 as there is no need for such a move as we do have a phase III trial running at the moment.
Page 14 of the protocol has the following to say about who gets what agent. The decision to give SNG001 to lower risk patients is quite telling.
'For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both “higher” and “lower” risk of progression to severe COVID-19.'
The doctor's words in the video are being misinterpreted.
Doc why are you always using such negative language these days?
"If they chucked us off"
"If that happened sp would take a hit"
What a load of rubbish!
If we we're upgraded to activ-3, if a body of evidence suggested it would be hugely beneficial to the affectivenes of our drug, then the share price would rocked up.. no question at all!
Have you sold recently and now hoping for another dip to enter before news? Possibly, hence all the negatively, suggestive posting ...
@35 mins.
TLWILLIAMS
100% agree with what you're saying. Activ-2/3 participants would almost certainly have been gagged on enrolment.
It is a 100% us government funded trial and they will control all data and media releases, that would be a totally normal and expected approach, also giving them first refusal on successful treatments imho.
1. Many contributors have expressed concern about the lack of comment about ACTIV-2 progress during Richard Marsden's recent interview with Proactive Investors London. The Full Year Results statement, which complements the interview includes the latter, as does the accompanying Chairman's statement. ( both quoted below)
Moreover, as the financing and administration of the ACTIV-2 trial are not within Synairgen's remit, would it therefore be inappropriate for Richard Marsden to provide any update as regards its progress?
From the highlights:
" SNG001 included in US NIH government-funded ACTIV-2 Phase II/III trial in COVID-19 outpatients in January 2021 and commenced patient dosing in February 2021. Phase II evaluation will see the recruitment of up to 220 participants."
Chairman's statement;
"The inclusion of SNG001 in the US government-funded ACTIV-2 trial is a further indication of international interest in our inhaled interferon beta treatment."
2. In recent days, two contributors to this board referred to Synairgen's "failed COPD trials". Comments in the full year results statement beg to differ.
From the highlights:
"Positive data from interim analysis of SNG001 trial in COPD patients supporting future progression of SNG001 for exacerbating COPD patients".
" Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date." (unequivocal evidence of the drug's safety)
I believe that these trials were suspended, with the company's priority shifting to Covid-19 trials. There is nothing here or elsewhere to indicate any "failure" during the interim progress prior to the trial's suspension.
The Full Year's results statement is detailed and comprehensive. Everything is reasonably straightforward, in sufficient detail, and above board. I look forward to the forthcoming results, particularly those from Synairgen's Phase III trials.
Regards and good wishes to all genuine Synairgen investors.
The other great news is that long after Covid-19 is over, and that won’t be for many years yet. Our drug will still be treating millions of patients with respiratory viral infections and saving billions in associated hospital costs.
The future for Synairgen is very bright
The great news is that in a few weeks more data will be added to the growing evidence of our drugs safety and efficacy. The chances are that the activ2 trial will find at least the same results we did in our home trial and the possibility find the results we missed in the placebo group. Either way I think it’s highly unlikely we’d have been kept on the trial this long if results were unfavourable. I’m feeling pretty confident that phase 3 is about to happen and although we may have some reservations about home trials and patient recruitment, a phase 3 admission to a USA led government trial is huge for Synairgens profile with the possibility of EUA
Er..... oak leaf
I don’t lie
I don’t deramp
I do, however, enjoy a good roll around
Boyg you are a liar and a de-ramper. **** off