Member Info for Matml74

Tim,

You can search the Rns’s on this site. All the information is in there relating to the azn asthma trial. But you answered the question in your post. It wasn’t taken forward due to lack of exacerbations in the trial. Nothing more than that.

Stay safe Dan and good luck mate.

Nice summary of the data Dudio. The main thing to remember here is that the statistical analyses did take into account the differences in comorbidities between placebo and sng001 groups and results after adjustments were "enhanced" in relation to benefits of therapy.

"However, these factors were considered in the statistical model used and beneficial signals for therapy were enhanced when a priori adjustments were made."

“On 26 December, LAS received 7,918 calls, while on 16 March - one of its busiest ever days - it received marginally more.
"The demand is occurring because of the rapid spread of the new variant of the Covid-19 virus, initially in north-east London, but now spreading into north central London and predicted to spread further across the rest of the capital in the coming days and weeks", the memo read.“

A Boxing Day to forget!

Wally, if you haven’t already done so go and look at the Synairgen readdit page. It has plenty of information, watch the videos of Richard Marsden and Prof Holgate, as I believe it is essential to understanding this company.

There are no guarantees in life but there is a large body of evidence that Synairgen have produced over a number of years that suggest this drug could really make a difference in treating a range of viral lung infections, and in particular, one that is currently royally ****ing us over!

It’s not less dangerous. If it was the government would be crowing from the rooftops. Certainly wouldn’t be putting half the country in tier 4! The fact is there are still many unknowns about this variant and the long term effectiveness of vaccines. I hope like hell they work and we don’t need to create new vaccines each year to cope with this bloody thing but we are at least 12 months from finding out if this is the case.

Wally posted this the other day regarding the terms variant/mutation.

“Just to be clear. Mutations are what create variant strains of a virus. They are not independent of each other. A mutant strain is the same thing as calling it a variant. It is where the mutations occur on the virus that will determine whether vaccines work or not. Covid has already mutated over a thousand times.

This is the reason we have yearly flu vaccines, generally to cope with the mutations of flu that occur during the Southern Hemisphere winter. It will be the same with covid by the look of it.”

Thanks Syn. Nothing wrong with a bit of ramping. Gets under the skins of the imbeciles who come on here with no knowledge of Synairgen trying to disrupt the board. Like yourself I am very confident here and excited for the next few months.

One other aspect of the phase 2 trial is that the team has learnt much on how to set this phase 3 trial up to ensure success. A couple of points from the article.

"The sample size of 100 patients (50 per group) in this pilot study was based on WHO recommendations that a pilot phase with 100 patients would be sufficient to inform follow-on clinical research."

"Multiple analyses were done to identify the most suitable statistical method for future clinical trials."

This is Synairgens moment to prove itself.

PS, Unfortunately that is not the case. It can happen but for the vast majority of viruses mutations cause no change in the severity of disease. For instance, Influenza mutates at rates up to 300 times greater than that of other viruses but has no significant changes in severity of illness.

Glen,

Pretty sure this is the only breakdown you will find for the study population.

Comorbidities
Hypertension - Placebo 11/27 (41%); SNG001 18/26 (69%)
Chronic lung condition - Placebo 12/27 (44%); SNG001 11/26 (42%)
Cardiovascular disease - Placebo 8/27 (30%); SNG001 5/26 (19%)
Diabetes - Placebo 9/27 (33%); SNG001 3/26 (12%)
Cancer - Placebo 1/27 (4%); SNG001 0 (0%)

In this study, SNG001 and placebo groups were well matched for age, sex, and overall comorbidities, but were less well matched for disease severity at recruitment and for specific comorbid conditions—particularly diabetes, cardiovascular disease, and hypertension.

"However, these factors were considered in the statistical model used and beneficial signals for therapy were enhanced when a priori adjustments were made."

Excellent post as usual SYN. Some food for thought for those that are having doubts about the quality of the data I suggest whilst the market is closed that you go and revisit the Lancet peer reviewed paper here:

https://www.thelancet.com/action/showPdf?pii=S2213-2600%2820%2930511-7

Key results:

Study Population:
• Patients in the SNG001 group had more severe disease as judged by 37 (77%) patients receiving oxygen therapy (OSCI =4) compared with 29 (58%) in the placebo group.

• More patients in the placebo group than those in the SNG001 group had diabetes (nine [33%] vs three [12%]) or cardiovascular disease (eight [30%] vs five [19%]), and fewer had hypertension (11 [41%] vs 18 [69%]).

Of note here is that diabetes mortality rates in covid in the general population are approx 7% and for hypertension is approx 6%. So whilst the placebo group had higher number of diabetic's the SNG001 group had a higher number of those with hypertension.

• There were three deaths in the placebo group and none in the SNG001 group.

Results -

• The odds of improvement on the OSCI scale were more than TWO FOLD greater in the SNG001 group than in the placebo group on day 15 or 16 (p=0·033)

• More than THREE FOLD greater on day 28 (p=0·006).

Results in the per-protocol population were generally better than those in the intention-to-treat population.

Significant effects were observed with SNG001 versus placebo for:
• Improvement on the OSCI on day 15 or 16 (p=0·017)
• Odds of severe disease or death (OSCI =5) on day 15 or 16 (p=0·041
• Time to recovery over the treatment period (p=0·033)
• Odds of recovery by day 15 or 16 (OR 3·18 [95% CI 1·21–8·39]; p=0·019)
• A non-significant improvement in earlier hospital discharge over the treatment period ( p=0·072).

Hopefully news of P3 start this week. GL

This is why the company and its partners are currently looking at BFS manufacturing processes to reduce costs and also massively increase production. Would expect this to be in play in 2021.

I’m in for golf. Currently on waiting list for Burhnam and Berrow. Very nice links course but long wait for membership. Always up for a hit though and if SNG pulls of P3 then will be ticking of as many top 100 courses as possible!

mm's wiping out some stop losses.

https://www.timesofisrael.com/man-who-died-from-second-bout-of-coronavirus-confirmed-to-have-different-strain/

Mate that one has been tried before. Didn’t work then either. Filter bin for you!

“The Company is targeting the end of the calendar year for completion of preliminary product evaluations, with full release of the final CE Marked system in Q1 2021“

Not long until point care is ready to roll. Feel this will be the big opportunity for GDR.

550k trade was above the Ask at the time of print.

"What would a conditional order of say 200,000 treatments from the US do for our SP, as well as create FOMO in the UK?"

SP would fly massively. I can't see this happening yet, which I do find strange as many other treatments and obviously the vaccines had preorders. Just seems to be the way with this treatment or their is more going on in the background than we are being made aware of.

I would like to see an RNS around the manufacturing and production of drug. To me this is what we have been kept in the dark about, despite two fundraising with significant amounts directed towards production. The info surrounding this has been very sketchy to date and we have been able to obtain more info from the job adverts on SNG's websites than in any RNS.

Rscorpio,

The power of 90% referred to in the RNS relates to the probability that trial will find a statistically significant effect when one actually occurs. So it only relates to the trial design and shows that 9 times out of 10 this trial design will determine that an effect, if observed, is true.

The p-value is used to calculate the power of the test. I would think this to be 0.05.