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They will test the device delivering the drug as part of the trial surely ?
The only Irish company mentioned in that EU support, that i could see, was VLE therapeutics, which is a private company. Goggle them, a very intresting story
GL
I wouldn’t disagree.
This is what it’s all about, Interesting, or perhaps very interesting times ahead.
Panic and an ensuing minor sh#tstorm judging by the petrol station chaos and empty shelves this morning. It is so good to have a diversion or two.
BW to all.
November, gosh October! Hoping for much more in November lol!
Trek
Irrespective of the signs this is imo due a decent run ahead of read out. Earlier in September was a false start. I think November could see 175 form a decent floor at last!
I also picked up a few here today. Will add rest after financial interims
Trek
Andy - I agree on the false alarms, expect the false alarms have never looked this obvious.
The giveaways are plentiful if one takes the time to analyse what was written in the quote. The device being the biggest clue and the confidence of success being a close second.
And if people on this board don't understand that a device has to be approved for use, not just in clinical trials but also for an EUA, then those people need to sharpen their act.
I wouldn’t worry, Doc likes to take the contrary view and if he ruffles a few feathers in the process so be it. Love the gentle put down by Oxford btw. Over to you Doc to check for us lol
It would seem reasonable that devices (even those approved) would need approval when being used with a new substance (therapeutic).
Assurance would be required to ensure no degradation of device materials ensues following use of a new substance (therapeutic).
In fairness gunto2020 there have been untold false alarms For LTH.
And I am by nature show me the proof type of bloke but given the geopolitical context I think the Eu have been roundly embarrassed to date so this seems ever more credible. If it is as useful a weapon as all the independent research points towards, I won’t be adverse to an unseemly pre bidding war.
Roll up ladies & gents, Roll up !
How much smoke do people need before they can detect the fire?
Doc, happy for you to “easily” check if the nebuliser needs approval.
Little clue, it certainly did for the trial, so why wouldn’t it for EUA or full approval?
"What about Dr Aurelien Mary and his outfit ? They are certainly using a nebuliser."
Do you see them on the list? No.
Aerogen will have to register their device for this application. That is basic.
Well all this can be confirmed next week in Q & A’s !
Friday feeling we always go up
Great work Oxford !!
The jigsaw is slowly starting to come together. We have all been here a long while. Think we can wait a bit longer for GOLD :-)
Can someone tell the share price to get excited?! :)
@Oxford and Matt
Thanks for the replies. In fact I just got back from dropping my good lady off at work.
Yes, I was 95% sure it was the nebuliser, could not understand why nobody had said it .
Anyway it sure is getting exciting now ( dare not tell the wife, she might want to stop working if I make a £Bundle )
Roll on Synairgen success and good health to the world.
It was “by October”
The first 5 announcement was “by July” and I think it came on 30 July.
Does anyone know the date in October that the EU list of 10 in total (Therapeutics) will be made public? Or did they just state a blanket 'October'?
Taverham. The big Irish company appears to be Aerogen interestingly not quoted in Ireland but Nasdaq
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.]
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.
I hope so Oxford.
Pay day today, so another late top up for me.
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?
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