Member Info for Bella6532

RingThe Bell...the Results RNS has these three highlights:
· Synairgen launched a Managed Access Program with Clinigen, to provide SNG001 to hospitalised COVID-19 patients - see separate announcement issued today
· The Company is currently in discussions with regulatory agencies to establish the route to approval of SNG001 as a treatment for COVID-19
· The Company is also investing in supply chain activities to ensure that drug and aerosol delivery system availability can meet potential demand, pending approval

The first - done and dusted...check.
The second - route to approval...this suggests possibly getting Emergency Use first to speed up the route to hospitalised patients prior to getting full blown approval. This appears to be the case now based on France and perhaps authoritites are holding off on the full blown approvals due to Brexit talks not being finalised so they are uncertain as to how they should treat UK drugs going forward if third country regulatory rules are different to EU rules or perhaps new special rules for UK only.
The third does imply to me that meeting 'potential demand' refers to that produced through the Emergency Use route prior to getting full blown approval(s).

I could be wrong of course...but I think we are seeing the EU Route starting to unfold...

Thanks Joey...but in order to implement deals struck they will have to agree or disagree by 15 October - well that's the deadline given by Boris. So 15 October is really so much more significant!!!!!

6 to 8 to 10...perfect...
Not wanting to split hairs...but we're not officially still in the EU or EEA...perhaps this might be why discussions have been going on a bit!!!
I'm sure now France have approved and are adding SNG001 to their ATU List the rest will follow as this is too important to split hairs over...

JoeyD... The French regulators are the ones who have issued the ATU for SNG based on info submitted by Synairgen... I'm surprised they didn't tell the markets about this as it is an emergency/special case usage approval.. Maybe they're just waiting for final confirmation from the French Authorities...
They said some time back they were talking to several regulators. Let's hope this is now the first of many with EU, UK and US about to drop any time now...
If available in France from mid Oct does that mean Ex Works or Delivered..
Interesting couple of weeks coming up...
Common Boris, don't let Macron steal your limelight....

DD77
My numbers are only for PXS own sales of FF+O.
The financials today cover thru year end which is up to end March 2020 and Feb and March were the two highest months by order number. April saw those numbers halved and they haven't recovered.

Now this is out there and the likes of Bruker are involved the Avacta story is going to start to unfold quickly now including any regulatory hold ups being 'pushed' along...Governments around the World are soooo worried about this coming Winter and economies cannot support another one or two full lockdowns...this is all great news and many thanks to those who managed to dig a little deeper with their research...big thumbs up.

Based on my O/N’s and same multiplier my estimated sales:
H1 19/20 = Estimated £59,999 (Actual = £60,000)
H2 19/20 = Estimated £67,731 (Actual = £55,000) so actual is down by £12.7K
H1 20/21 = Estimated £34,496 (Actual ??? – is this going to be down too)

Feb20 = highest month @ 5991 Orders
Sep20 = 2724 Orders

Fundraising needed next 3 months.
No-one will get to see IF live on Zoom…ha ha I wondered how he was going to get out of that one.

Next question...
If 100,000 treatments are to cover own sales... How many treatments might licencees be looking to make/sell...an unknown and not in any numbers put out by SNG.
SNG don't want to be manufacturers long term... They want to licence. This small volume is a way to simply fill the gap and put some money in the coffers so that going forward they won't need more fundraising...

OK here's a question for you guys...

Where did SNG get the 100,000 treatments per month from?
Is is based on current manufacturers max or
Is it based on potential clients giving some upfront order take info or
Is it based on CONDOR supply expectations or
Is it just a number SNG are pulling out of the air to keep investors happy... I very much doubt its this one haha...

Apologies if already mentioned but it looked like two large buys went through today.. One this morning and one after hours... Buyers market right now...

waferthintam...70% of cases in the US and Europe are now a new strain of Covid which is more contagious and the information you posted is huge...how many other treatments cover not only several viruses but different strains of Covid. Flu and Covid together are the biggest concern and I'm sure those in the know will be very worried....

Qd22...there is lots of info/research/articles out there about Interferon(s)...but they are muddying the waters slightly because the injection format doesn't cut it...the gold standard is Synairgens Inhaled Interferon Beta 1a Formulation.

MMMs are filling large orders....

Will those Doctors, Consultants who were involved in our hospital trial be more likely to offer SNG001 to their patients now and would they be telling their colleagues it's now basically available.
My mother had a rare form of cancer some years ago and the only effective drug was only available in the UK - not UK approved - and it was offered by her Consultant who said he would get it sent over and all he needed was her agreement and it would only be available to her through him and the hospital pharmacy. I don't even recall her having to sign anything and it arrived extremely quickly - as if it was available locally.

'Clinigen now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies; interacting with over 15,000 registered users across over 100 countries, shipping approximately 6.4 million units in the year.'

A Great way to get the ball rolling before regulatory approvals received...
No mention of other negotiations with distributors or Pharmas though...

New rapid swab, saliva and antibody tests do not have to be approved by a regulator. Manufacturers are required only to self-certify that they have met certain standards to get a CE-mark.

'GE Healthcare is an established technology component provider for point-of-care lateral flow immunoassays. We produce a wide range of cellulose and glass fiber substrates and nitrocellulose membranes to an assured quality for accurate and reproducible results.'

Think it's pretty clear what they provide...when did we assume they did more???

If the virus has mutated and is more infectious and it appears antibodies from the earlier strain might not be effective or so effective with this new strain...where on earth does that put the Vaccine trails???!!!! We know flu has many strains and flu vaccines are in the main based on only one or two past strains...

If Avacta need to validate their new production run...they've got plenty of uni students hold up and ready...lol...

Slide 27 Certification first for testing by Professionals in Workplace, Testing Stations and GP Surgeries, Hospitals (they said they wouldn't anticipate their test being used in hospitals as they already have their own onsite PCR Test facilities)...then certification for self-testing in Home and Workplace but no mention of Care Homes!!! ???

The app they are developing...Is this simply going to be a consumer type app where you keep track of dates you took the test and results so you can show details to others or will it be linked into the Govts app?

Metland...this not like producing leggo bricks...the science IS key here. They MUST get the Production right from the getgo...