Member Info for Fruitsnveg

Thank you chaps, I had overlooked some of those (points). Next week being week 8 should put us out of our misery, hopefully!

Agreed Maml. But RM said in the webcast that they 'hoped' it would work / and the RNS said it was 'currently under testing'. I assume therefore that they need to know it works sufficiently well before, for example, using it for any A2P3...?

Ghia,
Yes, I'm referring to the 3rd last bullet in that RNS - that's the reference to Woodstock Sterile Solutions. RM went on to talk more about it in the webcast here here :(https://seekingalpha.com/article/4457817-title-synairgen-plc-syggf-ceo-richard-marsden-on-q2-2021-results-earnings-call-transcript). The reference to "(currently under testing) using polyethylener blow-fill-seal container technology" is what I think is still in progress and my guess is until that is complete we won't be green (or red) lighted for A2P3 progression. I think it's contingent on that testing being complete. Do you agree?

There's been a lot of noise about when we might hear about A2P3. The reference to Woodstock Sterile Solutions by RM last week in the webcast was noteworthy, and I think too overlooked by many here. In their own words, "Woodstock Sterile Solutions conducts preliminary studies to determine a formulation’s sensitivities to temperature, pH, oxygen, and other factors. Understanding the formulation early in the development process, we can address those challenges to make a robust, scalable product for clinicals that translates well for commercial manufacturing."

If we are switching from Akron to WSS technology for fill activities, the FDA will want to greenlight the output, before it goes into further trials (i.e. A2P3). Think of it as a material change from A2P2 to A2P3 which would require a series of tests before getting a green light to proceed. I can only assume different fill technology may affect all manner of things, like storage temp, dosage, who knows what else. I think it's a possibility that this is why we have not yet heard news about progression to P3. My guess is they are waiting to see if this technology works and if any material change to how they run a further trial.
Thoughts?

I'm glad I'm not the only one mulling this over Doc83. Until proven otherwise, I share your sentiments.

Ghia,

"They are not aggressive buyers". I'm (genuinely) interested to know why you think this? Their history of involvement in such scenarios is in the public domain tells me otherwise, are you basing your statement on how they have approached similar investments? If one is focussed on acquisition fees, it cares little if the SP is driven down to achieve a cheaper price for a client. Especially if one's average buying n the dips is now sufficiently low to absorb any gap. No client wants to pay more than they have to and there are ways and means to achieve that. If I was a PI that MO would not be working for me. Not at all.

It will be interesting to know if their end goal is to be paid chunky aquisition fees (gasp)..... or, like most PIs, to turn a profit on their investment through a SP rise on release of results.

Depending on which one, it's either a confidence booster as you say TLWilliams, or a potentially very upsetting play ahead....

Andyb4,

Do your homework. If Merck get EAU (it's not a done deal), their drug treats a different stage of Covid (early stage, unlike ours which is later stage), and with data on mutagenicity, they won't get EAU for anything other than a small sub set of patients. The experts are agreed on that.
Read up on it. You're talking nonsense when you say they've stolen billions worth of contracts from us. They haven't. They'll have a share of the market just like we will if we both get approved. An early stage drug will be a welcome adjunct to SNG001's late stage treatment, good luck to Merck, who, you never know, may well end up licencing our drug one day, or more....

Yep, going back to where we should be. Much to the chagrin of some posters here no doubt....

Understood Matterhorn, thanks for clarifying.

I am still of the opinion that if SNg001 works and governments want it, future stockpiling for pandemic preparedness decisions will happen in 2022 - they already kicked tat can down the road for a decade and look where it got us. IMO it won't be a decision that will be pushed out again. They risk of getting left out in the cold with a broken supply chain (think Pfizer, Israel and USA debacle or the EU's slowness to react to vaccine ordering) should be enough of a lesson learned. I have zero doubt that the overwhelming economic impact of the last 2 years will force government action, once an approved therapeutic like SNG001 hits the market. It will be first come first served, and as we've seen with AZ and Pfizer, countries scrambled to ensure supply and are still scrambling to ensure supply.

"Britain is heading into winter with the number of Covid cases remaining at a worryingly high level. At the same time, the nation’s vaccination programme appears to have stalled."
https://www.theguardian.com/world/2021/oct/03/we-might-not-be-over-the-worst-scientists-warn-as-covid-case-numbers-stay-high

Matterhorn, Stu,
Worth noting that every year Tamiflu is stockpiled by governments (in 2017 alone it generated total sales in excess of $18bn, roughly half of which could be attributed to pandemic stockpiling). Claims by Roche, the manufacturer of Tamiflu, that the drug reduces hospitalizations and serious complications of flu were a key factor underlying stockpiling decisions. governments stockpile it because it's available and it cuts hospitalisations and deaths. If and when SNG001 is available I see no reason for it not to be stockpiled too. I don't understand why you think this decision would be pushed out a few years? That makes no sense.
The global economic imapct of the past 18 months pandemic has been unprecedented and immense. Governments simply cannot afford a repeat in 2, 5 10 years with no drugs in a warehouse ready for the next virus. (I will caveat that by saying that UK gov have proven themselves over the past 18 months to be exceptionally disorganised, lacking in foresight and incompetent ( look at the various messes of PPE, Covid Testing, HGV driver shortage/Petrol...etc etc)) but I don't think they will let pandemic planning slip as far down the priority ladder as they would have done if the country hadn't been brought to it's knees in 2020/21. If they do, there will be no shortage other countries who have suffered more that won't lack that foresight and willingness to engage (e.g. India). Stockpiling contracts will either happen in 2022, or not at all IMO.

https://www.insidermedia.com/news/south-east/synairgen-progressing-well-with-latest-venture

A lack of long-term data may limit initial rollout to high-risk people. If the drug receives regulatory support, doctors will likely determine treatment eligibility based on the patient’s risk-benefit profile. That will result in a much smaller, more targeted use base. This won't be a drug for the mases, or anything near that IMO, at least not until certain questions around safety have been fully studied and addressed, and that may be a long way off.

Also, I picked this up online earlier and it too is worth noting:

Dr Simon Clarke, Associate Professor in Cellular Microbiology at the University of Reading, gave his expert opinion today -
"It would be good for the 50% of patients that it could save from getting seriously ill, but not so much for those who are still hospitalised, despite taking it. There’s currently no way of knowing which group someone will be in. It’s worth remembering that another drug, dexamethasone, was found to save around a third of people who would have died with severe Covid-19, but its clinical introduction did not prevent nearly 100,000 deaths in the UK in the past twelve months."

If Molnupiravir is for mild to moderate cases, and SNG001 is for severe and hospitalised but not yet critically ill, then I'm not sure why anyone would think hospitals are not going to stock effective late stage drugs like SNG001 if they are proven to work. I'm not sure why they would think Merck are going to corner the market for 2 different uses? The drug failed in late stage disease treatment trials. Do they think Molnupiravir (if approved) is going to stop hospitalisations globally?

Here's an expert view:
Ruth McKernan, Chair of the UK Bioindustry Association, said:
“The addition of oral drugs directed specifically at the virus for use in the community is a really valuable addition to our toolkit. They have good efficacy and should work across many variants. We need a full set of treatments from preventative vaccines, oral treatments for those infected and additional drugs for hospital use.’
Note the "and".
-"Oral drugs" = i.e. Molnupiravir
and
-"additional drugs for hospital use" = i.e. SNG001

So the experts see oral drugs as a great addition to the toolkit, and this is comforting for those amongst us worried about the market available to us.

Did someone send in the clowns?

As always, highly entertaining.

Back in April there was a major issue of mutagenicity regarding Merck's drug. Unless data is available that proves it is not and is in fact safe in the long run, then EUA won't be granted without it. Does anyone know if those studies (to check if it's mutagenic) concluded and if so what the outcome was?

"Didn’t SNG have an 80 - 89% effective at reducing serious illness??"

Yes it did Mike. Top that Merck.

I think if Synairgen show the US Regulator that they can pivot to a different fill system using Woodstock Sterile Solutions, that would definitely in our favour. It would free up manufacturing space for vaccines and boosters yet ensure a separate and concurrent run of therapeutics at the same time, de-risked by the fact that we would be using different fill technology than others.
I'm wondering if this POC (for want of a better word) is what the US Regulators are waiting on, to explain the time it's taking for A2P3 news...?

Interesting that 8 weeks ago Polar Capital were still focussed on the value of virus-agnostic antiviral therapeautics. @ 3.48 here:
https://www.polarcapital.co.uk/gb/professional/Investment-Insights/Post/4004/The_Covid_effect_on_the_healthcare_industry/

"Long term". It's good to hear our large II put their mouth where their money is.