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Hi,
Ive not posted for a while, but I have some good news to share.
Here’s proof that Synairgen were at the EU covid therapeutics matchmaking event in July. Remember this event was part of the EU strategy to accelerate Covid therapeutics?
Synairgen is definitely involved.
See detailed event report below, and list of participants at the end of the report.
Plus an “anonymous” testimonial:
“After the presentation of the experts on Monday 12 July morning, we noted a great synergy between the recommendations and requests made in terms of treatment guidelines (presentation by Prof Roche) and what we are developing at our company.
If the results are positive, which we have no doubt they will be, we will have to consider an accelerated procedure for the registration of the product and the devices. We now know the contact persons to move in this direction.”
Anyone else think that a Covid therapeutics with devices sounds like Synairgen?
Here’s the report link:
https://clustercollaboration.eu/sites/default/files/event_calendar/Proceedings%20Report%20-%20European%20Matchmaking%20event%20-%20Development%20and%20production%20of%20COVID-19%20therapeutics.pdf
Not many things get me excited at this time of night But Oxford12 that works.
Very nice to have you back - One heck of a come back.
Ha ha! Thanks Andy.
So nice to see some proof.
Welcome back Oxford12, great sleuthing.
I suspect RM threw us a clue there with the code word 'synergy', the old devil....
If anyone missed the EU covid therapeutics strategy, here’s what it covers:
“It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use. It will also coordinate, scale-up and ensure that the EU acts together in ensuring access to therapeutics via joint procurements.”
They are aiming for regulatory approval across the EU and manufacturing support. 5 drugs were selected in July (mostly Mabs) and 5 more are due to be announced in October. Synairgen must have a high chance here and it would be game changing.
Thanks again Oxford12.
Fruitsnveg I love the idea of an innocuous line holding hidden meaning.
It does seem in context, but I choose to believe your suggestion as with this news, it will help send me to sleep with a big silly grin.
Thanks for the link,Oxford, and the reminder.
I vaguely recall we had several discussions about our possible/likely inclusions some months back when the therapeutics task force was set up. Then sleuthing and speculation went dormant on this chat.
All in all, a timely reminder. Thank you again.
I wonder if the Synairgen Research (Ireland) entity was set up to somehow qualify the company access to all the EU players (manufacturers, CRO's peers, etc) that would have taken part in the event? The Irish entity was registered in June, I think... Or is it unrelated?
I’m a bit sceptical.
I find the following sentence not referring to Synairgen for two reasons.
‘… we will have to consider an accelerated procedure for the registration of the product and the devices. We now know the contact persons to move in this direction.”
1) Do you want to tell me Synairgen have not considered accelerated registration and had not known who to contact? They’ve been working with the EMA since last year so surely they knew how to go about.
2) With reference to ‘registration of devices’. The Aerogen nebuliser is already used in hospitals so it does not need registration. Unless it requires specific registration with SNG001. I also find it odd that RM would speak of ‘product and devices’. I’d say he’d rather just speak of ‘product’.
Matterhorn - I can see your reasoning why you're sceptical but then you could ask, based on your sceptism, why would Synairgen need to be there if they already have enough contacts etc.
You have to agree though, Oxford12's find makes a nice read.
dactions - my scepticism refers specifically to the comment and not as to whether Synairgen attended or not. That may not have been clear from my post.
I don’t doubt Synairgen’s attendance (and would not be surprised if they were there since they’ve been ‘close’ to the EMA). It is after all a networking event/opportunity so I would expect them to be there, should circumstances allow, irrespective of the fact that they would’ve known who to contact.
Are there other potential treatments due that use devices?
Sorry. I'm a bit groggy, just woke up.
On page 5 it mentions:
Manufacturing
Fill and finish, including device for delivery.
What is that device?
Ok I'll go back to sleep
Morning,
The fundamental point is the proof that Synairgen are definitely involved with the EU therapeutics strategy.
So you would expect that they have applied for support as one of the “big ten”. Then the big question is - is SNG001 one of the 10 most promising treatments in the world? Will they be selected in October?
If so, they could get massive support to scale up rapidly, get EUA across the EU countries and joint procurement.
Thanks Oxford for sharing but, I don’t see that this is concrete evidence that we were in attendance and certainly that we provided the statement.
Of course, I hope I’m wrong as this is more evidence stacking up.
Kevin, the testimonial is anonymous so pure speculation on my part.
The attendance is there in an EU report. It is titled, list of participants, so I think that is unambiguous.
AL, the device in SNG’s case is the nebuliser.
Synairgen have shown consistent forward thinking to put all necessary in place.
A good example was seeking protection for Interferon / steroid treatment combo.
Another seems to be Synairgen Research (Ireland) Limited. That was created in June presumably in anticipation of seamless access to the EU ?
One thing we all know is that the SNG board are extremely professional and doing everything needed to bring an exceptional product to market.
Of to the Belfry to lose some golf balls (Europe Europe)
Have a good weekend all
Gold
Andy, ref Ireland- am I correct in thinking the nebulizers are from an Irish firm and if so that may explain our presence there and also support access to EU markets?
I hope so Oxford.
Pay day today, so another late top up for me.
Many thanks for your contribution Oxford12; additionally to everyone involved in the ensuing discussion. The net effect has been to clarify my thinking on something that I had previously glanced over, and set to one side, purely because the EU were involved. Your point may be speculative Oxford 12, like so much other information contributed on this board, but it is plausible.
Regards and good wishes.
Thank you for such an excellent find Oxford12.
The quote belongs to Synairgen:
"... and what we are developing at our company." [they are literally developing a treatment that can combat COVID, and the use of 'what' indicates a singular agent and the use of 'developing' indicates R&D.]
"If the results are positive, which we have no doubt they will be" [echoes of Sir Stephen Holgate on Sky News. They are extremely confident of the P3 results due to the P2 trial plus the decade+ of developing SNG001. They knew it would work from Day One of the pandemic. I don't believe there are many other companies in the running displaying this level of confidence that use a device with their product.]
"we will have to consider an accelerated procedure for the registration of the product and the devices." [Who else is using a device in the method of delivery? The device screams 'nebulizer'. Furthermore, there will have to be a separate approval provided to the Aerogen neb for COVID . Just like in the USA with the FDA or any other major healthy regulator.]
We now know the contact persons to move in this direction.” [A company of less than 100, working flat out on a Phase 3 trial, manufacturing preparations, speaking with various regulators across the world etc. They need all the advice and input they can get. This matchmaking event would have saved them a lot of time and the provision of direct contacts is priceless to a company of their size and distinct lack of resources.]
Taverham. The big Irish company appears to be Aerogen interestingly not quoted in Ireland but Nasdaq