Member Info for Saxondale

Two elements we haven't heard any updates about :

In the 28th Nov 2019 RNS regarding Clevegen - Markku stated that ' in due course ' they planned to apply for Breakthrough Status in the US and Prime status in Europe .
This would help fast track them through regulatory interactions .

FDA states it will respond within 60 days of a request .
So perhaps we applied early Dec - we are now 60 days on approx
Prime status in Europe with EMA . Submissions entered by deadline of 8th Jan 2020 - would get a SAWP (The Scientific Advice Working Party ) recommendation ( ie decision ) by the 13th Feb 2020
To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data. By the looks of it - about 25% of those applying for PRIME status get accepted .
So we may have 2 possible bits of news coming shortly on that side of things .

Cheers hadn't seen that . I've seen plenty of articles with Gilead mentioned , nice to see Faron in there now.
The virus will eventually recede , but ARDS was around before and will be after .

Hi CB , looks like we both pick winners lol . Added a few more today - and gonna enjoy the ride . Whoever it was that did a cross ramp campaign the other day - hats off to you sir :-)

Indeed , and 5000 man has been back in again .
In the periods of no news , they certainly help themselves to cheap shares don't they .

The fact that the share price is even moving about is a bonus compared to a few dusty shares i've got . At least is means something's going on in the background lol .
This share lost 85% odd in 2018 - so those folk took the big hit for us ( thanks )
I think if we were just pinning hopes on Traumakine , they may be able to shake us down to 90p again with the fear factor of its all or nothing , but we have this rather good looking back up called Clevegen now ( its made alot of progress since those sub £1 days ) .
Large dose of Patience ( and patients ) required .
Many big investors have been holding tight since the early days - like someone said , no TR1's of investors moving out , just buying in .
I should have traded a bit at the £3 mark , but never did . Who knew it was the top at the time . If it hits £3 again , I probably will take a bit , but then , unless it goes bonkers real quick , it will be balls of steel time to hold through to the big money .

Found this on Youtube

https://www.youtube.com/watch?v=okg7uq_HrhQ

If the link doesn't work - look on youtube :How Coronavirus Kills: Acute Respiratory Distress Syndrome (ARDS) & Treatment

Quite interesting , yet even in 2020 , the only 3 ways they seem to have come up with to treat ARDS is :

1.) Ventilation - but low volume ventilation necessary to stop inflating the alvioli - so more co2 floating about - not nice for patient
2.) Anesthetic or paraylsis induced to steady the patients breathing ( not nice either )
3.) turn em over - 10-18 hrs a day on your stomach

All this they think reduces mortality from 40-16% ( if you've got access to an ICU and ventilator )

No mention of a wonder drug being developed by some Finnish guys . oh well .

Also recent press on Coronavirus reports Govts approving use of unlicensed drugs in order to see if any work .
Gilead - massive company ( £5.9 billion turnover ) Chinese researchers explored patenting one of Gilead's experimental drugs to combat the novel coronavirus outbreak ( the one than didnt work on Ebola )
Taiwan is chucking money about trying new drugs .

I think one thing is for sure that will come out of this - people will learn alot more about ARDS .

Just looked on their website - to check that they hadn't gone bust or something - all looks good .
Latest news from them which they seem very proud - 8th Jan 2020 LYOCONTRACT is now officialy FDA certified .
Thats handy

Been trawling through some old RNS info from 2017-18 when Traumakine was being prepared for global launch .
5th Feb 2018 - A second manufacturer of the FP-1201-lyo was announced - Lyocontract GmbH . They actually supplied some for the trials , and were going to jointly help produce the massive volume of treatments along with Rentschler .
So they already had another supplier lined up as they knew they were going to need plenty

29th Jan 2018 - FDA Grant Traumakine Fast track status

4th Sept 2017 - US FDA proposes proceeding directly to Biologics License Application (BLA) submission for Traumakine

This would get it onto the market much quicker in the US .

As Zen states , PIM already granted in Uk , but also I think it had orphan status too .

So given that all that was in place in early 2018 - the only thing that put the brakes on were the poor results in May 2018 - basically that steroids were interfering with the drug .

Surely - with that now proven , and new protocols designed to work with that , added with an even more pressing need to help treat the symptoms of Coronavirus - we should be in a good position to take the brakes off .

Back in 2017 when the BLA was suggested by FDA - SP was up 2% to £7.15 .

Then factor in the 2019-2020 Clevegen progress - which could possibly dwarf the Traumakine program .

Exciting times

Very true . Nothing wrong with the company - quite the reverse . We just have to sit tight . Timing is hard alright . Ive been sitting on a few grand of EUZ and EUA for over a year ( bought EUZ first by mistake thinking they were EUA lol ) . Everytime EUZ gets good news , the SP drops - holding shares there has been like some sort of Japanese endurance game .Was gonna cash some in today to top up here , but i'm pretty loaded here , and its nice sitting on 3 fireworks now .

I liked this bit about Clevegen :
Good tolerability at all dosing levels without dose limiting toxicity, leading to the announcement of the first expansion cohort in CRC patients in Jan’20, where there is a significant unmet need and a near-term path to approval

With such a delay in update , I'm super happy that its a good one . I see this a great step forward . Onwards and upwards

One thing that gives me some reassurance when we are in these sort of times is that they raised £7 million without any issue back in late Nov @ 1.90 . That carries them through 2020 with Clevegen ( if they go it alone ) . Im assuming you don't get £7 million without people being confident things are going in the right direction .
Without it , they may have had a partner come in on the cheap as saviour of last resort . Maybe they already had some partner offers , but knowing it was worth more , they knew they had to strengthen their own hand to show they weren't reliant on a partner .

Important for us and the SP , but for Faron and the team , it is their careers - and the making of the company if they pull this off properly .

You have to think that the original partner for Traumakine is still in the picture , I feel it may be the manufacturing side that is holding things up there before they can announce the next step , as the API manf process needed upgrading etc etc

Am I right in thinking we have the 2 day LSX conference starting tomorrow ?

900 odd attendees , 2000+ meetings

Lets wish our team good luck !
Their blurb says :
For 5 years, the LSX World Congress has been bringing together the executives that matter to the future of healthcare and life science business strategy, investment, partnering, deal making and commercialisation.

LSX World Congress gathers the founders and CEOs of innovative start-ups through to publicly listed life science giants, and everyone in between. It represents the breadth and depth of the cutting-edge research and technology driving the advances in the industry right now and in the near future.

Always depressing to see a slow puncture on the price - especially with only £60k traded . I'm poised to add a few more - I did at 240 , could have had some at 229 this afternoon . I remember it sinking to 147 odd in Nov when I did top up . But since then we've had so much development progress with Clevegen that surely they won't be able to push it that low again , and remember that was when it shifted up to 295 . I was in the states on holiday that week - woke up at 3am to check price on phone - its was showing 320 ! went back to sleep dreaming i'd be a millionaire by morning . This time next year !

Everyone goes on about Father Christmas trips to Lapland , it only just clicked that Lapland is actually in Finland .
Which is appropriate cos it feels like Christmas is coming , and we've got two presents under the tree .

Balancing that out is the opinion that Santa is an imaginary made up character designed to make us spend money and get into debt in January .

Have a good weekend all :-)

Welcome Gargar , funny i took a little punt on that share 2 days ago after the cross board ramping campaign ( call me naive ) , gonna hang in a day or so longer see if it has legs . Maybe we should do a campaign on Faron - and get all the loonies in - spice things up while we are all navel gazing .
Back in July Markku said in an RNS he hoped to conclude the Clevegen partnering plans by end of H2 2019 .

One of the GGP chat comments made me laugh and think of Faron . He said that there were so many clues and hints splurging out of the cracks that it was inevitable that good news was coming .

Luckily we don't get social media splurging , just RNS facts , Proactive interviews , and a shiny new website with shiny new videos and a Partnering Pipeline spreadsheet with a splurge of blank spaces .

Been digging through old news from that Stockwire site - came across this from June 2016

Faron Pharmaceuticals has entered into a licensing agreement with Pharmbio Korea Inc for the development and commercialisation of Traumakine in Korea.

Pharmbio is based in Seoul and specialises in hospital sales of novel pharmaceutical products.

Traumakine is in development for the treatment of Acute Respiratory Distress Syndrome (ARDS), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment.

Traumakine is now in the pivotal pan-European Phase III INTEREST trial.

Under the terms of the agreement Pharmbio will obtain exclusive Korean rights to Traumakine. Faron will receive an initial signing fee of €750,000, which will be recorded as a revenue in H1-2016 financial results, and is entitled to receive additional, undisclosed development based milestones. In addition, Pharmbio will pay Faron one third of Traumakine profits, representing a double digit royalty on net sales, depending on end user pricing, and has agreed to cover development costs for Traumakine in Korea. Additionally, Faron will provide European approval material for Pharmbio to obtain market authorisation in Korea and will also supply Traumakine drug product to Pharmbio at an agreed transfer price.

I wonder If that still has any relevance in todays setting , ie would this royalty payment still be coming in from Korea ? Or do these agreements have a limited lifespan and conditions ?

Just been offered 242p for all mine . If I'd tried some day trading today could have made about £10 . Not worth the risk lol

Swiss Nordic Bio is a high-level partnering and investor conference . 200 attendees maximum - looks like 184 already signed up . 61 of those list themselves as in the Investment/ Licensing . Presentations going on all morning - The Faron guy is first up presenting at 9am - so at least half should be paying attention . Then pm is one to one ' matchmaking meetings' as they call them . Sounds like some sort of pharmaceutical speed dating - lets hope they pick our contestant number 1

Hi Red , funny you say that as Condor was what I moved out of to come here . I suppose there was too many 'what ifs ' and ' hows' still to answer there . If I do well on other shares and have some free profit I may drop in again if it hasnt taken off by then . This one however just seemed to have all the boxes ticked , and with a LOM that looks like just getting bigger and richer . I also had a fairly big holding in Hummingbird since the heady days of first gold pour - and we all know how well thats gone , despite it looking like a no brainer on paper .I also have a few Cora , again good vibes but low SP , and funding still to happen . I made a few U turns on investments before Christmas , and spread my money into a few other companies , ones that had management that seemed a tad less shady lol . I'm still a beginner at this game , and the AIM market , which is where I dwell , it certainly is the wild west at times . Thankfully its just a hobby , so not losing sleep overnight when things start going Pete Tong . Ideally I'd have a nice wedge in all of those mentioned , but the wedge is a bit smaller than it was 12 months ago ( thanks to SXX) , so hopefully ive placed my bets on the right horses now for 2020 , and lets see how it goes ! Learning the hard way haha