Member Info for Saxondale

The manufacturing agreement gives them the scale etc that FDA would be looking for regarding a Fast track approval , plus for their planned expansion of cohorts .
So that box is ticked .
FDA should decide within 60 days of an application .

So far - the trial detail is fairly limited - recruiting , but only 6 hospitals listed . 650 patients as a target .
I expect we will see that being updated and expanded .
On 28th Nov 2019 - RNS says - Faron plans to open new study sites in the US to facilitate a rapid expansion of part II of the study.
AGC has manf plants in US and Europe.

I just don't know if the success of Traumakine - will change their plans on Clevegen regarding partners ?

Just massive decisions - and without being involved , we can just speculate .

Personally , I don't think Markku would want sell the company . He will have plenty of rewards and Kudos . A great team involved , family etc , and more inventions in the pipeline . He doesn't look like the kind of bloke who wants a yellow Ferrari.
Saving the world and sleeping well should do him for now .

Good find Copper & Cwebb thanks

The Stockholme Arbitration Inst seems to clear the majority of its cases in 6-12 months . Faron only announced its case on 30th Dec 2019 - so maybe a wait for any payoff .
Their announcement about using Lyocontract back in 2018 would have given them large scale production , but who knows what they have planned .
The lyophilised manufacturing method must be at the forefront of their plans.
Maybe the clue was in the name of that manufacturer?
They are always one or two steps ahead of where we think they are anyway .

Never thought I'd been on it , but just discovered I actually joined Twitter in 2009 - ahead of my time !
Over 10 years - and yet to post - now there's restraint.
Might try to restart it and get #ing
But then - will we not be in danger of losing out on Faron being 'our little secret' lol ?

Just got back in , not seen where share price had got to yet today .
Took another few grand at £3.71 thank you very much .
Swapped it across from a gold share that's doing well , but even so , this , at some point , is going to do a whole lot better .

They are doing everything right .
Top tier manufacturer onboard with seamless scalability to full commercial global roll out .
Every time they turn a card over , its an Ace !
Well done Faron team - keep it up :-)

support their discussions with global regulators ?
Previous RNS stated : The Company is in the process of filing for Breakthrough Therapy status with the FDA and Prime Therapy status with the European Medicines Agency, which if granted, could provide an expedited development and review path.

Dr. Markku Jalkanen, Faron's CEO, said: "We are pleased to initiate this agreement with AGC Biologics preparing for commercial scale manufacturing of Clevegen. This will allow flexible and cost-efficient manufacturing to fulfil the growing need in our clinical development programme while ensuring rapid and regulatory ready scale-up of the production for future potential commercial needs. This will be important to progress, alongside the clinical development of Clevegen, and will support our discussions with global regulators as part of the end of phase II meetings for Clevegen. "

global contract development and manufacturing organisation AGC Biologics has been selected to be the commercial scale manufacturer of Clevegen.
Like the sound of that !

Actually , I think its been there all the time , I just noticed it yesterday lol

Some useful videos posted up yesterday on the REMAP website ( in the Media section ) - giving a bit of info on how the adaptive trials work .

Heres one on the sample sizes - shows that they are constantly monitoring the data , rather than waiting for the end point after all recruitment has been done ( as in a traditional trial ).

https://www.youtube.com/watch?time_continue=241&v=IL2tLJkqIFQ&feature=emb_logo

Possibly another avenue where Traumakine can be effective

Reports have been dotted about for a few weeks about patients with Covid 19 suffering from silent hypoxia , basically where their lungs are only saturating 70% or less oxygen rather than a normal 95% . Very odd , and people don't even realise they are that serious , and can result into quick decline and organ failure and death .
Farons pipeline for Traumakine include2 two cohorts for multiple and single organ failure - as IFN beta1a has been targeting that very issue along with the main ARDS study .
Their pipeline - only in stage 1/2 for MOF says-
Traumakine's mode of action, i.e. the production of adenosine via up-regulation of endothelial CD73, has been shown to be essential for organ protection during ischemia and reperfusion in several animal models. Traumakine, therefore, has the potential to provide protection to every central organ sensitive to hypoxia.

https://www.theguardian.com/world/2020/may/03/happy-hypoxia-unusual-coronavirus-effect-baffles-doctors

https://www.faron.com/pipeline/organ-protection-ischemic-conditions

I suppose the reason why the don't have a broker target is it's just so hard to put a number on it .
We have 2 world class drug therapies on the verge of commercial success .
And an Mcap of £170m
Interestingly - historically , Panmure Gordon always had a target price of about £7.60 .
As of Feb 2020 - is it showing as ' currently under review '

I see two stages to big double figures

Firstly a Traumakine green light - in current circumstances - and with a third party join up - has to get us to £10 min but could just rise and rise as demand will be unprecedented .

But stage 2 will be worth waiting for - both in form of a partner entering a cohort of Clevegen , or the fast tracked development of the therapy , which remember they are applying for . Who knows , but after a small slice of profit , I will be keeping my shares to see where it all leads .

There will have to be some clinical response to the data we are getting back on REMAP soon .
It's only been a month , but this is an accelerated trial .
We will fit into this somewhere that is 100% guaranteed .
Govts need all sorts - from testing kit to preventative drugs , to therapies , and vaccines .
There will be room for a number of therapies .
Ours is easily distributed across the globe requiring minimal equipment .
No sucking plasma out of patients or giving them a 1 in 4 chance of croaking as a side effect.

I am gobsmacked how we are being kept under wraps .

The Faron T shirt is ironed and ready to be revealed Superman style on the day we get the green light !

I think you'd have to pay to read the whole report published today - but nice to see Traumakine and Faron top of the list.
Finally we are getting some coverage !
https://www.marketwatch.com/press-release/acute-respiratory-distress-syndrome-ards-pipeline-insight-clinical-trials-and-pipeline-assessment-2020-2020-05-01?mod=mw_more_headlines&tesla=y

Political muscling will only get a drug so far Itsall .

I bet Markku wasn't far of this while Trump was blathering on about his wonder drug

https://www.youtube.com/watch?v=Lvc4fJEhQpY

Zen , I've added about 4 times this week . In hindsight I should have done it months ago , but had to balance risk and reward .

I've had a few wobbles over the last year , but now sleep well with what I have here .

The pension funds , and placing just added to the confidence I have .
It doesn't have to happen next week.
But we know it will happen .
It will be a sweet day that's for sure , and it couldn't happen to a better company .

That proactive update summed things up to a tee .
The sleeping Giant is stirring .
In a few days / weeks something will break the SP stalemate , and some of use will be kicking ourselves we didn't add more .
All the LTHs can do is sit tight and wait .
The seeds of success have been sown .
Those that know the company well , will have just added this last week .
I still have a feeling that the next RNS may take us all by surprise though . Faron are clever - and are one step ahead of where we think they may be .

Even in the latest interview , Markku was stressing that Traumakine wasn't using much of the current budget . I feel he is still planning on it becoming a collaboration with a third party ( big Pharma ) . He doesn't want anything to detract from the Clevegen program . he knows Traumakine will work - and will be huge , but he doesn't want it to be at the expense of the Clevegen timescale . Sounds daft - but Clevegen has the potential to be even bigger . Hence the placing . Like Zen says , he's been kicked in the nads once with Traumakine - ( to the tune of 90% of your share price ) you don't make that mistake twice.

So close to cashing in at least half of my stake yesterday , but just couldn't . The story , the excitement , the facts . So instead I went to bed early , slept like a log . Happy this morning , and added a bit more this afternoon . Looking forward to the next chapter now . Full time job this week chugging through posts , but I felt I had to , and enjoyed many of them . I can sit back and relax a bit now i think .