Member Info for Matml74

Absolutely spot on Sandgrounded. I am looking forward to seeing the valuation that they come up with. Plenty of news coming here over the next month.

The website is great but it is the large number of high level and critical US job openings that tell the story of what is about to come.

Matterhorn,

1.4 z score = 1.4 standard deviations from the mean but you would need to know both the mean and standard deviation of the study population to work it out. Whilst you can guess/assume different mean scores for placebo group, as we don’t know the variation in the sample I don’t think this can be worked out accurately. As far as I can tell SNG did not release the raw data (means/st dev’s) for the P2 so can’t use those numbers to try and work out a ballpark.

“How many >50% efficacy drugs have come to market now for COVID...”

None!

The FDA has fully approved 1 drug. 14 have EUA’s the majority are MAB’s in outpatient setting. There certainly is no drugs that are approved for Covid with moderate to severe disease in the hospital setting that has 50% efficacy.

All these amazing drugs doing wonders for the US at the moment.....

Zero logic in that post. “Preparing to live with it”’doesn’t mean that people are going to stop catching it, end up not being able to breath and end up in hospital. If anything having a really good treatment for those who get ill is the most important bit of “preparing to live with it” and makes the drug a more valuable commodity not less.

I did Doc. It was a small sample size (31) Long covid sufferers and 8 of those had very severe disease so you might expect higher levels of cytokines with them. It may be a problem but I think there is not enough understanding about long covid yet to get too concerned. I suspect if you can control the virus early and quickly for those with poor innate immunity then long covid won’t be an issue for most.

Brand, there is a graph in the April presentation that shows for the mild/moderate cohort there was no difference between SNG vs placebo in recovery time. I guess it depends on what is trying to be achieved by treating mild covid disease. I believe that Activ P3 is taking a more targeted approach for SNG001 and focussing on the breathless at home. I think there will definitely be a roll for the drug in that area. I think we probably got through the Activ P2 by showing good viral reduction and if that is shown to be of benefit, particularly in terms of long covid, then there might be wider application for the drug.

Brand, All good points but IMO they have worked that out already. It's the breathless. I went back through the April 21 presentation today. It is really quite compelling piece of work and really highlights why the breathless cohort is the one the drug works best in. I recommend all take a read again.

A p value of 0.004 is a very significant result!

NDN, Seriously? They have phase 1 and phase 2 trials for a reason which you obviously fail to understand.

You don’t want to battle with it but always have the last say. Like many it seems I am wasting my time responding to you so will give up.

“ And the study sample size specified was still a guess, even if an educated guess, of how large a study needs to be and they got it wrong with the home cohort in phase 2.“

A few points here. Firstly on the phase 2, they did not get it wrong it comes down to finance. No way SNG would have been able to raise the funds required to set up a highly powered trial on their untested drug on a new virus. That is a ridiculous statement that they got it wrong and does not take into account how you finance a trial and what the purpose of a P2 trial is.

Secondly if you read the protocol there are some valid quite conservative assumptions made, which are also in the protocol, which every clinical trial needs to make, to determine small size.

I will post some more about this later as I went through the protocol yesterday but out and about atm....... and the protocol clearly states what subcohorts will be looked at which will keep you happy NDN.

Blue, You can take that approach or you can follow Polygons approach and buy more. Depends on your risk appetite.

In my view the approval risk here is very small. This is not a diagnostic device like to company you alluded to it. It is a viral agnostic treatment for respiratory illnesses. These drugs are very difficult to develop. So the risk here is in the readout, but the way the company has been behaving of late suggests to me they are confident they have the data.

In Synairgen's own words from the trial protocol......

"Success will be determined if at least one of the primary endpoints is declared statistically significant by the primary analysis. A sample size of 610 patients in total using a 1:1 randomisation ratio (305 patients per treatment arm) has been chosen to provide at least 90% power to detect a hazard ratio of 1.45 in time to hospital discharge and a hazard ratio of 1.7 in time to recovery and at least 95% power to declare statistical significance on at least one of the primary endpoints. This sample size has been calculated using a global 2-sided alpha level of 0.05 and adjusting for the Hochberg procedure to allow for multiple comparisons. This also allows for an interim analysis to assess futility after the first 300 randomised patients have completed the Day 35 visit or have withdrawn from the study."

So they could try and work the numbers all they like but "success" is based on the above.

There is very low volume now. There was a surge of buying a few weeks back which held the price up around 210 but since Polar dumped some shares on the market which Polygon happily snapped the volume has dried up. It seems that at this stage that the vast majority of shares are tightly held and no one is prepared to bid up the price to extract them.

Doc, I agree. A lot will dependent on what kind of initial orders come in and also the potential to scale up manufacturing to a lot than a million doses a year.

I think we will here news on new manufacturing suppliers on a positive readout.

Marik, it has benefited from no generics coming along to compete with it as it was actually hard for generics to be competitive on price so morning all that $100b was made whilst the drug was under patent.

But it does show the potential here as I believe we may be able to get a patent life of around 15 years or so with extensions.

BC, Advair a COPD/Asthma drug that when approved had a 9 year patent life generated $100 billion in revenue for GSK so I think there may be a fair bit of interest if we get a efficacious readout for SNG001!

NDN, the elderly, due to these findings, are more likely to dominate the trial participation numbers so will be the main cohort ;-)

Yes I saw that and thought it was deserving of its own thread.

Whatever variants come along it will always be important to be a Ken to effectively boost the innate immune response of the elderly.

“Older individuals with severe COVID-19 displayed type I and II interferon deficiencies, which is correlated with SARS-CoV-2 viral load. Elevated expression of SARS-CoV-2 entry factors and reduced expression of antiviral defense genes (LY6E and IFNAR1) in the secretory cells are associated with critical COVID-19 in aged individuals. Mechanistically, we identified strong TGF-beta-mediated immune–epithelial cell interactions (i.e., secretory-non-resident macrophages) in aged individuals with critical COVID-19. Taken together, our findings point to immuno-inflammatory factors that could be targeted therapeutically to reduce morbidity and mortality in aged COVID-19 patients.”

https://onlinelibrary.wiley.com/doi/full/10.1111/acel.13544

There really isn’t any reason why an immunomodulating drug that supplements the innate immune system would have differences like that and the sample size of 600 people will be too small to look at intricacies like that in any case IMO. The trial design is such that the people on it are at a stage of disease whereby their innate immune response has failed so by rights, if the drug does what it says on the tin, it should be beneficial for all...... not just the redheads.

As to the degrees of effect the way I look at it is that the results will be presented as an odds ratio. IMO odds of recovery is the more important primary endpoint. So the question is if you are struggling to breathe in hospital with covid at what point would you be prepared to take the drug..... if it gave you 20% better odds of recovery over standard care, 30%, 40% etc. etc.

The regulators will decide what that level is if the results turn out to be more marginal but for me I would be prepared to take a drug if it gave a 20% better odds of recovery with few side effects.

I do hope however the results are similar to P2 and taking drug gives you twice the odds of recovery over standard care.