Member Info for marik

It's positive news:

- as a minimum SNG have exceptional belief in the product on 17 Nov
- best scenario the results are positive (it's unlikely as it makes a huge assumption that SNG had visibility of data)

Either way, positive news with phase 3 results around the corner. Prepping up for EUA application!

@BeContrarian, that would be correct. It is what would normally be required for NDA as post-marketing requirement. Here as we know the process is expedited and SNG will apply for EUA. If SNG have sight of top line data before this trial start, then this has positive implications, and if they don't have sight, it shows exceptional confidence in the product.

GLA

In addition: this 25 person trial started November 17, 2021 and the Synairgen announced completion of Phase III recruitment on Nov 11th. My assumption was that data would be unblinded mid-Dec. With that in mind, I would say that I'm more inclined to believe that SNG & Parexel will have added this extra part of SNG018 in readiness for EUA. Let's assume that they had no feedback from the Phase 3 or MAP or Phase 2 Activ-2. With the trial completion next Monday, it would make sense that Parexel and Synairgen are preparing to expedite the drug approval process following announcement of phase 3 results. I would assume phase 3 results are to be released very soon and EUA application submitted very soon after that.

@BeContrarian, that would be correct. It is what would normally be required for NDA as post-marketing requirement. Here as we know the process is expedited and SNG will apply for EUA. If SNG have sight of top line data before this trial start, then this has positive implications, and if they don't have sight, it shows exceptional confidence in the product.

GLA

I'm loading up, whilst the penny drops.

GLA

Brilliant. thanks to @gggg21

Looks like it is the post-marketing requirement for new drug application!!!!!

Some great responses (with vast majority constructive). As @Manifesto has put it with respect to SNG private investors, "...Investors are too well informed to be influenced by them". Completely agree. This is one of the best informed boards I've come across, thanks to many of the seasoned posters and the new and has been so for long time.

Keeping my previous caveats in place. I thought I'd put some thoughts together. As we know our focus is strongly on the US [1], which has a strategy to stockpile for future variants and new pandemics, with analysts stating a stockpiling strategy of 5-10% of the total population as being reasonable. Which would equate to > 48-93m units (US: 16.5-30m units, EU: 22.5-45m, UK: 3-6m, Japan: 6-12m + many other countries). Demand would outstrip supply and 100,000 units just wouldn't be sufficient. Even if we give a lead time of approx. 10 months, this just wouldn't be enough.

A 100,000 units for the US market alone would imply 1m unit production (i.e. 3-6% of the actual requirements). 1 million unit/m scaleup could potentially reach a 66% of the US demand. Demand from other countries in this equation would become a huge scale-up effort on part of SNG.

One poster (upupandawaybby) pointed out that: Analyst estimates used sales of 250,000 treatments per month i.e. 3 million a year for target SP of £75. This is indeed a very good point. Of course, we go with a one step at a time strategy, looking forward to the results.

1. https://news.bloomberglaw.com/health-law-and-business/biden-looks-to-invest-30-billion-in-preventing-future-pandemics

"Popcorn and drinks machines remain in situ and merely need refills and the margins are incredibly high, as much as 1500% markup with popcorn."

@RS2002, the margins are very healthy. It doesn't need much to breakeven. The current Russo-Ukrainian conflict should have no impact on the SP (*) unless of course investors are not aware that there is "no supply chain issues with product, microprocessor glut or other inflationary concerns that could stub the movie release process, either".

GLA

(* even though the Russian-Ukrainian issue will be resolved in the coming weeks with high level diplomacy already in progress as of today in France.)

"An SP of £75 was based on us selling 250,000 treatments per month so just 3 million a year
Our first pre order after P3 could be 10 million treatments on its own for USA"

@upupandawaybby that is the very interesting part as the US would not be the only country wanting to stockpile. I sense that there will be an impressive array of RNS to follow the results.

"Palladium just touched $2200"

Only time I've had to fight back the tears (of joy) in the last year.

:’-)

527 cinemas in the United States
127 cinemas in the UK & Ireland
35 cinemas in Poland
27 cinemas in Romania
18 cinemas in Hungary
13 cinemas in Czech Rep
10 cinemas in Israel
7 cinemas in Bulgaria
3 cinemas in Solvakia
0 cinemas in Ukraine
0 cinemas in Russia

That's right folks no cinemas in Ukraine or Russia. No movies from those regions to impact sales. Expect this back up to 44p fairly soon.

Nice post Wiggly.

Agreed @theboyg, Government help will certainly go a long way.

*With the caveat that the results are positive (as per ALL previous phase 1-2 SNG trials).*

The question for me isn't about 100,000 units per month. I would be asking how long after positive results can SNG start producing c. 1 million units per month.

Pfizer's nirmatrelvir was ordered on EUA at 10 million units and with a lead time of approx. 10 months. (@100,000 units that would take SNG c. 8 years). I'm expecting a dramatic scale-up well beyond 100k.

The placing in October 2020 was given the following context:

"The gross proceeds of the Placing will be used to:

...
· fund SNG001 manufacturing and device scale up activities, with the aim of producing c. 100,000 treatment courses per month in 2021..."

As you can see some of the proceeds from the October 2020 (see 14 Oct 2020 RNS [1]) fundraise was already allocated to manufacturing scale up with an aim of 100,000 treatments per month.

Clearly the target is immediate EUA application and manufacturing are in place already with SNG001 given to patients within months, see the comments from Richard Marsden on the webmd interview (15 Dec 2021 [2]):

"JOHN WHYTE: Your best guess as to when the drug might be widely available?

RICHARD MARSDEN: So we get data early next year. And if the data is really good and if COVID persists as a problem, then we hope to file for an EUA. And there's precedent there from other people's programs, in terms of how long it takes from data through to submission through to availability. And that's measured in months in this pandemic, not years like it might normally be."

i.e. from data release to availability, is measured in months.

GLA

1. https://www.lse.co.uk/rns/SNG/placing-and-open-offer-hwyvj20u13tq1ig.html
2. https://www.webmd.com/coronavirus-in-context/video/richard-marsden

I like your positivity DOC83 for "Windfall Wednesday" : )

"We're all wondering why there has been no RNS."

That's not completely true, I am not wondering about this, for good reason.

1. The current trial is >620 patients (much more than the phase 2 trial) and will take more time to analyse
2. The importance of getting it right on a phase 3 which will require EUA shortly after is even more important

For that reason I would expect it to take slightly more than before. I'm expecting it at anytime from here on.

GLA

Although some have suggested that stockpiling is a requisite for share prices in excess of £15 per share, however, I would say that stockpiling will become a *must* for most countries with future pandemics inevitable. Let's not forget the future covid-19 Variants of Concern.

GLA

FinnCap put the price of treatment at c.$1,000 for a course, which I would contest as being undervalued for stockpiling, but non the less, this would amass close to more than $10b in annual sales.

With stockpiling potentially reaching a staggering 80 million units (5-10% of the population of the US, UK and EU + a proportion of the RoW), I would be very surprised if Synairgen do not have to scale up dramatically in the coming months and well beyond the 100,000 units per month they are currently on.

In short, they are likely to sell all they can produce and still have a huge demand still to cater for.

No doubt collaborations of the highest magnitude will be required.

GLA

Once the p3 results are out very shortly, the price will more than recover.

Good evening Ian,

Could you put me down for tomorrow after hours.

Thank you Marik

His controversial comments was hugely popular amongst the anti-vaccine, anti-mandate demonstrators and conspiracy theorists.