Member Info for Matml74

Here here. It certainly is Welsh.

Well done to the SNG and Parexel teams for getting this over the line. I imagine it was an immense amount of work.

Plenty of strong messaging in that rns. Unsurprising that UK gov/MHRA don't get a mention. The UK health ministry and regulators should hang their heads in shame.

A peer review is required when the data is to be published in a scientific journal. It has nothing to do with the regulatory process.

Regulators have their own mechanisms/experts for reviewing data so peer review will not hold up any regulatory processes.

Regarding trials it would depend on the type of virus but SNG001 is an immuno-modulator. It does not act directly against the virus like the Merck drug.

This time last year John Bell said covid would be over by April 21! So I guess he was a year out.

Saint,

I agree. MCAP does not currently reflect the future upside. IMO investors are pricing in a risk factor for P3 failure that is way too high for a drug that has successfully negotiated 4 P2 trials (1 run independently) and currently undergoing two P3 trials.

There is no way that SNG001 will end up with orders in the 100’s of millions upon Sprinter success....... they will be way higher than that.

Ndn,

There are a few reasons.

Firstly there is significant competition for trial patients in hospital settings so spreading further and wider enables more chance of getting the trial numbers more quickly.

Secondly, Due to the duration (14 days) of the treatment and data collection trial staff are unable to manage large numbers of patients at any one time.

Lastly, It will be relevant when seeking approvals in each of these countries. Parexel have had to go through the long drawn out process in many countries of getting regulatory approvals in each country to get the trials off the ground so should ensure speedier authorisations and rollout of drug should SNG001 be successful in its P3 readout.

24 outstanding as of end Sept 21 plus whatever they have drilled since then, so 30 +.

Juri and Scally as well. Plenty of updates coming this quarter.

I think it will be delayed so that they can get more infill drill holes into the MRE. As of end of September they were still waiting on 24 outstanding drill hole assays. A delay will just mean a larger MRE2 so would probably prefer the slight delay so more data can be included.

* should read £400m mcap for SEE!

They are a £150 billion plus market cap. SEE are £400 mcap. Broker coverage costs money and so not sure that is a fair comparison. Personally would rather they spend their funds winning more contracts.

I am sure when SEE rerates to a multi billion pound mcap then broker coverage will increase.

gggg21, It doesn't even need to come in at P2 figures. They were exceptional. Any data that shows a significant reduction in time to recovery/time to discharge/death/intubation etc and multi billion pound orders come in for SNG001. Simple.

Order discussions with volumes must me a fair way down the line as well hence the advertisement of a second director of CMC.

They have been playing it since June. How else do you get 15% of a company and hardly move the SP.

I would rather them than the flaky PI’s who sold up.

Could be a number of reasons.

Improvements in standards of care since early in the pandemic might mean progression to severe endpoints may take longer.

There have been many cases where ICU stays are 3 weeks or longer (Median stay on some studies I have read are 19 days in ICU) and for some patients progression to ICU stage can take several weeks from hospital admission so those would be missed.

There are a range of countries in the study with differing standards/quality of care and hospital resources etc compared to the P2 which was England only so this may affect the timings for some of the patient outcomes.

Why does the SP need supporting? Volume is tiny it's not going to move anywhere significantly while no-one willing to sell/buy. IMO they would rather it drift down to add more.

Great title!

"Accumulating data suggest that SARS- CoV-2 proteins can modulate IFN responses. Data also suggest that SARS-CoV-2 infection induces an MDA5- dependent IFN response in human epi- thelial cells. These studies raise multiple intriguing questions, namely: (i) how pro- tective are IFNs during early stages of COVID-19? (ii) What are the identities and modes of action of the main ISG ef- fectors in vivo? (iii) What amounts of viral proteins are sufficient to inhibit IFN re- sponses in infected cells? (iv) How do the interactions between IFN responses and viral proteins differ in different cell types? (v) How can the kinetics of IFN re- sponses inform the development of more effective candidate therapeutic interven- tions against COVID-19? Thus, the nu- ances of SARS-CoV-2–IFN interactions and the protective or detrimental out- comes in COVID-19 patients must remain an area of intense investigation."

https://www.cell.com/action/showPdf?pii=S1471-4906%2821%2900214-3

Yes would be the perfect time to drop a major auto win. Surely they must be close to closing out some of those RFQ's.

Polygon 15.4% tomorrow.

Marik, These numbers are decided by working out the statistical power of the study and whether or not the sample size used is adequate to show that an observed effect is not just something that can happen by random chance. SNG and the FDA worked out that 610 patients still provided enough statistical power that a positive observed effect with a p-value of 0.05 would mean there is 95% chance that that observed effect was real and not just by chance.

Now the Pfizer trial had 3000 patients enrolment figure and that would have been decided based on the statistical power of the study hence why I questioned the 770.

Patagucci. Do you have any idea of statistical power and how it relates to endpoints and hypothesis? Why did they test vaccine efficacy on 10's of thousands of people? Because a small proportion of people within a population catch the virus.

How many people who catch covid end up in hospital? A small number.

Add a comorbidity? A slighly larger number.

How many people in hospital struggling to breathe go on to intubation or die? A pretty significant number.

An observed positive effect of a drug in someone struggling to breathe in a hospital bed requires a much smaller sample size to see a significant statistical effect compared to seeing if hospitalisation is reduced when a drug taken early in disease in relatively healthy population where the hospital admission rate is likely to be very low in that population........ this requires a much larger sample size.

Nice one Marik. Its an interim readout so they are trying their luck IMO, particularly with the Merck approval yesterday.

I would think that sample size of 770 patients would be underpowered statistically to show a significant result based on the setting a stage of disease.

One thing Pfizer love is a headline grabbing efficacy figure, which eventually gets downgraded over time when true data is revealed! Pfizer vaccine now down to 39% for stopping covid infection!

Post of the day Axe.