The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Still holding, letting AS and the platform do all the speaking and also the countless clues being given out by avct.
If the data is as good in mice or a little bit less or a little better than in mice then Avct will be sold to the highest bidder no doubt about that, wouldn’t surprise me one single bit if a bidding war started between a few big pharma companies, in fact I expect it will.
Diagnostic arm pulled off a huge blinder of a surprise. Cut out the middle man and have a plethora of diagnostic test to put affimers into over time, also avct have their own AffiDX brand to push into the market direct with less barriers in the way. Avct have a strategy in place and will go on a targeted M&A spree to take the lions share of the market, consolidate the diagnostic market with the M&A plan within EU and possibly with global reach… which I also expect avct to have plans for. Avct haven’t purchased Launch on a punt, they have a mid to longterm plan for it, and will look to monopolies the market over time, which will push AffiDX branded tests and more importantly affimers to the forefront of home use testing. The cancer treatment platform is the golden goose… how many golden eggs it lays will be decided by the data market and eventual buyout.
For a long time now this share is being traded hard off the back of rumors speculation pumpers and dumpers and TA.
Nice one Energyshare
Very very very expensive to manufax only 5000 units, costs more to manufax 5000 units then the price to sell them. Don’t think Abingdon would ever entertain an order of 5000 let alone any other manufacturer. Abingdon would laugh at avacta, telling them to take their business somewhere else and show them the door out.
I’ve never done tech transfer and I suspect no one else has either on here, so I myself am not able to answer that question. Contact Abingdon or do some research on Covid LFT tech transfer. If someone else with experience and knowledge can tell us all how TT works and the time scales, without any unforeseen delays problems or pandemic, then that would help others including myself on how TT process works.
Seeing that Abingdon are the manufacturing partners for avacta, then the only thing I as an investor can do is go by what they say. I’m certainly not invested in any other company or person other than avacta and their business partners… so I go by what they say, I do my own research due diligence on the information provided and try to find extra info/research that backs the companies market position. If I feel that the investment stacks up for me and is worth my money and time then I invest… totally my own risk for investing, no one forced my hand.
Others who invest, have their own reasons and methods on how they choose to invest. Others that are invested are free to choose what information they digest in order to make their investment choice(s).
From abdx circular fund raising share document
AffiDX:- processes/manufax of three production scale runs progressing well and due for ‘completion this calendar year’.
‘Significant order post Tech Transfer has been received from avacta’
Abingdon Heath circular doc paragraph pic in tweet:-
https://twitter.com/jaykay_jayk/status/1468884382777843717?s=21
Agile life sciences and Medusa life science share the same registered business address. Peter Whitehurst is director of both CO’s :- Kemp House, 160 City Road, London, United Kingdom, EC1V 2NX
If he is linked to Medusa19 which looks highly likely seeing as Medusa19 life science share same brand identity as Mudusa19 lft site, Peter Whitehurst is a great person to have onboard to get into major retail shops and brand development skills. Think Medusa19 Life Science is set up for research & development also brand building for future products internally and externally. Peter as the director running the ship, with backing from boohoo boys, would be a great candidate, lots of previous experience to get the job done with huge science health and big high street retail contacts to tap into.
Non-Executive Director for the Brand Cloud (natural, organic health & beauty brands). Experienced management team in place and major retail listings in M&S, Sainsburys, Holland & Barrett, Harrods, Selfridges etc.
SSL international PLC
Chief Innovation Officer (Product Delivery)
Global responsibility for Innovation, Regulatory, Quality and Go to Market functions (Packaging & Artwork, Project Management and Product Portfolio Mgmt) for all New Product Developments for the Durex and Scholl brands (prior to RB takeover). Working closely with Group Marketing Brand heads to ensure the new products are in-line with brand strategy and meet the needs of the markets
Ah ok, thanks for being honest much respect energyshares. Still a good find from you and a good write up who ever the mystery person is. Makes a very valid assumption that Moderna could have taken Affimer into a human trial using AVA004.
avacta July 2019 PDF pages 9/10 seems to confirm what the write up is implying… wonder who the mystery writer is, it’s like a mystery within a mystery!?
energyshares great mini thesis, and detective work.
https://avacta.com/wp-content/uploads/2019/09/Avacta-Group-July-2019-16-9.pdf
Found this: on pages 9,
- title says fully funded partnerships
- shows Moderna logo on there
- showing Moderna timeline you have pointed out
- AVA004 PD-1 title in Moderna bar frame timeline.
Page 10:
- first time in-human for affimer platform
- again in milestone section show same timeline of Moderna:- exercise deal right 2019/2020 ind filing/human trial H1 2021
Both pages have AVA004 PD-L1 on them.
Actually think your right in what you’ve said in your writeup. AVA004 cld be the first affimer based trials in humans, could be getting an RNS on this from Moderna.
The Moderna partnership is fully funded by them, so all hard work paid for to derisk AVA004 PD-1 and avacta tmac pipelines.
Almost certain UK MHRA will follow IVDR regs 217/746. Keeps UK aligned with EU, basically makes MHRA job easier. The fact regs 217/746 is robust in assessment of IVD tests, means EU Notified Bodies will have done all the hard work. EU/CE mark carries weight globally 12/15
IVDR EU regulation 217/746 would be the best route. Receiving CE mark for self use under this default regulation will in-force 217/746 into all 27 EU states, regardless of individual states own policy & laws regarding in-vitro diagnostic (IVD) tests for self use 13/15
Which ever route taken AS is determined 2 get EU CE for self use. He shld be, why!? because it opens up global markets for #avct AffiDX “Lets not forget CE Mark has been historically the passport for approval in majority of international markets” Golden pass to global markets 14/15
And looks like EU CE mark certificate for home use is finally granted. No more waiting, second guessing, what ifs any more Med19 #avct find themselves in a unique position to take lion share of self use market. Certain they will do and smash it. 15/15
Link to tweet with evidence pics:-
https://twitter.com/jaykay_jayk/status/1461628766875262987?s=21
‘Who (what) is EU Notified Body Med19/#avct cld be working with’ to obtain EU IVD self use CE certificate. What EU state cld they be from, is it coincidental they are located in Spain, same city hospital area avacta used to verify AffiDX lft, Med19 have a Spainish website 1/15
On EU NANDO database from 18 Notified Bodies (NB) Med19/#avct could be working with ‘AEMPS Notified Body’ who certify med product devices under EU directive 98/79/EC for self use in-vitro diagnostic test (IVD). If not, then 17 other EU Notified Bodies to work with 2/15
EU Notified Body much like mhra/fda. AEMPS NB is located in Spain/Madrid/Delgado. Same country, city, hospital area #avct used to independently verify AffiDX. AEMPS CE certified AffiDX for professional use, was application for AffiDX CE self use submitted around same time. 3/15
Both EU Notified Body & hospital used to independently verify AffiDX are max 5/6 miles from one another. Google map shows location distance. Think this isn’t a coincidence, has Med19 planned to validate lft in Spain. Cld be why AS said Med19 doing superb job in Q&A 4/15
All 18 Notified Bodies are accredited by EU, robustly checked for compliance and adhere to EU special directive 98/79/EC for IVD self use, and certify them. Notified Body/manufax requirements & scope of works in pics 5/15
Cont from post 5/15: Notified Body/manufax requirements & scope of works in pics, Is not exhaustive to list but can be much wider. Tweet 5-6 pics from EU commission doc 2021. Question & answers on how to obtain CE mark and certificate for #covid19 IVD LFT for self use 6/15
EU Notified body: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) from Spain Madrid is one of 18 listed EU accredited Notified Bodies, who are on EU commissions NB Nando site. PDF shows scope to CE certify IVD for self use under EU 98/79/EC Directive 7/15
Wld be logical/easier for Med19 to use EU Notified Body in Spain Madrid. This only applies if Med19 submitted application before or on 25/05/21, after this date new 2017/746 regs apply. Med19 not applied by 25/05/21 they wld take IVDR 2017/746 route to CE mark AffiDX 8/15
Even if EU notified body AEMPS isn’t working with Med19 & #avct there is 17 others that can do same work. Med19 can only use one from EU 18 list. Spain hospital, Spain notified body, Med19 Spain website would be the perfect plan to obtain CE IVD self use certificate in EU 9/15
Tweets 1-9 apply if application for EU CE IVDD self use was before or on 25/05/21. If after 25 May then new regs IVDR EU 2017/746 apply. EU NANDO data base show only 6 Notified Bodies on list who certify under new regs IVDR EU 2017/746, Med19/#avct are using one of them 10/15
Med19 conducted submitted lay user study forming part of application to Notified Body on ease of use by non-professional (lay user) Going by medrxiv report which #avct did with Spain hospice users were non-professional. Med19 wld hav same trial success for self use CE mark
Didn’t get wrong number the screenshot shows time duration of call and Medusa19 number.
Everything that I put in tweet has been straight facts from Medusa themselves no extra meat added on to bone... no need for me to do that. There was plenty of meat on the bone already, I just went straight to the butchers (Med19) and asked about the quantity of the meat!!??
The person I spoke to was very professional, friendly, knowledgeable and family man… not a dog by any means.
Cheers beinthelead
‘What’s the fascination and suspicion? There was nothing new revealed in the ‘chat’ anyway? If he was going to the trouble of lying/ramping, you’d think there’d be more rampy stuff in there.
AS has stated Medusa have made an excellent job of the submission, it takes a while, and it’s imminently expected. Jaykay/Medusa said the same. Just took a lot longer.’
Cheers Robbo89
‘Tim as you state you left a message. If Jaykay would make up his story he woudent have been able to get a 1 hour 33 call time as it goes to voicemail inside 1 minute.’
Said it was coming very soon:-
https://twitter.com/downunderfutbol/status/1461340275247251456/photo/1
Those who haven’t properly read my tweet re: Med19 1hr 46mins conversation do so… with reference to today’s news. Wasn’t a waste of 1hr 46mins, same for the person who took the pics of the Med19 brochure and shared them.
:)
gmcc no worries, what I’ve shared is what was spoken of amongst an over all wide scope covid conversation.
The addressable diagnostic market(s) are going to be huge for avacta diagnostics side of business. They know that once they have all the necessary paper work and certification in place for Affidx, next time around it’s going to be much easier for them and bridges will be built with gov departments/notified bodies/countries/businesses/distributors etc. The tone and words used where ‘extremely confident’ ‘now just waiting on EU notified body’ ‘everything and everyone is ready at a push of a button’ ‘strategy/plan is in place’.
Yes Yorkshireman AS has a few bones to pick and points to prove. The thing is, he’s going to do it because the product works, and he has Med19 backing him. Avacta & AS are on the verge of doing great things.
We all would have found out along time ago if Affidx had not got through the process by now, if not sooner. EU notified body would absolutely not have waisted this much time if it did not see Affidx being fit for purpose. By now the EU notified body would have informed avacta that Affidx will not be getting EU IVD self use certification or EU IVD CE mark!!??
Going (gone) Deeper Underground.
PL75 has got right idea, to why EU is preferred HUA first. its in my tweet (in very short) which gcmm (thanks to him) has posted:- posts 4/9-5/9. Also much thanks to all who have positively posted.
Once EU certification is given to Med19 & avacta, by an EU accredited notified body, for self use in-vitro diagnostic lft test (IVD), which will be given under EU legislation directive 98/79/EC, because Med19 & avacta will have all the required certification/lab data/docs/paperwork/product diagrams/Affidx independent lab verification/IVD EU CE marks etc in place, getting HUA from apac and other countries will be a far more easier time and cost saving process, more of an altogether halved paper exercise.
Granted EU IVD self use certification for Affidx, in Med19 & avactas own back yard, will give other countries a huge amount of confidence and comfort in giving the Affidx lft HUA as well.
The hard work and thorough due diligence has already been done by Med19 & avacta jointly with the EU accredited notified body within the EU. Paperwork/docs and requirements required for other countries will be more than up to scratch to take forward to other countries, albeit a little different in process depending on country. Going into numerous countries all at once is very messy, costly, even more time consuming unknown way of doing it
Obtain an EU IVD self use certification and IVD EU CE mark speaks for itself. Too other countries, its a resounding gold standard pass given by the EU. First Med19 & avacta concentrate on EU (their own backyard) then its much easier to go into other countries, and more likely Med19 & avacta get the outcome they will be looking for without half hearted attempts, costs, long drawn out processes.
Once med19 and avacta get what they want from EU, almost immediately they will move onto list of territories/countries/markets they have within their sights, try and get the lion share. Again most has been hinted by AS in presentations. Also thats the steps I would take if it was me. Other businesses take same strategy going into other territories… Dragons Den great program to learn from.
Currently EU process is running at the pace and tempo of the EU notified body, just like it would anywhere else.
Self use IVD lft is a relatively new product and consumer market, even more so being fast tracked by covid which has been the catalyst in many different new sector fronts. For now govs and regulatory policy makers are taking a cautious approach on how to implement policy framework and regulations around IVD self use testing. Once everyone gets comfortable with the idea, see beneficial results of self diagnosis, it will become an every day regular part of life, everyone will move on to the next conundrum. Self use will be a gigantic consumer money spinner on many health and well-being fronts, and it has started with covid opening up the flood gates.
Thanks very much… everyone who’s ramping/deramping, in their own style/way, want a piece of the pie re: avacta. Just depends on how big that piece is and how much it will cost at current sp position.
Understandable!?
Convo was today 9:42am, 1hr 46mins start to finish with no hold, pic proof from my phone of time it happened is attached to tweet.
I assure those who have right attitude, no ulterior motives will have no problem in believing that I made call, and conversation was had. Those that do not, I have no problem with that. In a calm professional friendly manner conversation was about whole covid situation, how it has changed life, gov ineptitude globally ‘as well as about med19/avct/Affidx’.
I have no problem in people calling me ramper or convo is a complete hoax, that is your choice for putting your reasons/motives above all else. Fact is conversation happened I disclosed as much of info I could.
I dont post on here, because of the lunacy and absolute driveling stupidity that some post… be it ramping or deramping.
Most of info put in tweet is already in public domain. Look listen, forward think from a business perspective about next steps to be taken, read between lines. Everything has been repeated by other informed PI’s, hinted/discussed in presentations by AS. Those who can forward think from just day to day thinking, would have thought going forward what will Med19/avct next steps be. Some already know this, posted.
I got reassurance I needed, where things stand with HUA and moving forward. A great convo with a professional well knowledgeable person. What ever your motives position is in all this, don’t mind me, carry on as you are.
Oo.. also AS is still very eager/interested in establishing Affidx in own back yard/UK. He will do this with med19 once HUA is given. Self use will be main driver for covid testing. By the sounds of it he’s not looking to give an inch or leg room to anyone else, don’t think Med19 are either, I wouldn’t expect them business is business… no friends in business. Pride, prove a point, arrogance, not giving up, make a name for himself in UK diagnostics, get one back for himself and Co, money are drivers. That’s understandable, no brainer.
The convo was not in Macdonald’s lol (genuine laughter) at home sitting with my mom opposite me thinking Im chatting up some bird on phone.
Twice submitted for some info or docs, be it small or large info/docs is how slow/incompetent EU HUA body have been in process, with delayed replies upto 3/4 weeks before asking for next info/docs to be submitted. A long unnecessary drawn out process.
EU has to proof off some info/docs for Affidx consumer use product, it’s EU legal requirement to do so, makes sure all info on box/product is correct before product is launched and person uses it. If EU want changes made to any info product carries then med19 have to comply, then wait for EU replies on change. That is process they are currently doing now. Once those templates are proofed of by EU HUA body, then changing them to other languages/print is a very bog standard easy process.
No hold on phone a straight 1hr 46mins of an insightful covid wide scope conversation.
H
Denny11
Go onto Tiziana website bottom footer will find all contact details including phone number, Hanna is the person that picks up all calls and emails as well as being one of the managers at Tiziana.
I completely understand, and that’s why I got on the phone and discussed what is going on and how investors exactly feel. If this all goes pair shaped then the reputations of the board are tarnished forever, I for one will expose them at every given opportunity. They prove us all wrong and do what they promised us/investors, and do what they set out in their strategy and pipeline.
I whole heartedly know where your coming from, was the only reason I got on the phone and spoke to Hanna who has to take all the calls and read the emails.
As far as I’m concerned the BoD who hide behind their desks are the ones who need to seriously answer investors concerns in full and in a clear manor… they pumped and ramped to end, and since placing and collapse of SP both Kunwar and especially GC have disappeared. “Mother’s Milk” ain’t going to cut it and neither is “accustem is 40% better than the competition” the time for that talk has completely ended. Time for the BoD to step up and prove the pipeline is worth investing in or have their reputations tarnished with investors and industry professionals alike… simple.
Don’t know how someone would vote for something that had no information on what is being voted for… I’d think legally that would be found to be wrong and illegal!!?? I’ve had no correspondence from my broker IG, checked Tiziana website no information on scheme or voting on accustem, checked Twitter account no information and no notification or information via an RNS (if still applicable). If voting is going on with no information on full scheme details given to investors, then that is illegal to do so and Titiana would be in serious trouble with serious ramifications, I for one would not take it lying down and get legal advice and pursue a legal challenge in court.
Called Hanna at Tiziana, at 4:06pm on 29/10/21 conversion lasted 17 mins.
I have spoken to Hanna asking her about accustem voting rights/scheme details. She said that things are moving forward, and soon all investors with accustem shares will be able to see/receive accustem scheme details and vote on them soon. They will be published on Tiziana website and details provided through investor brokers. There is no voting on accustem as of yet, so those who say they have voted, both me and Hanna have no idea how that can be!!??
Re: Tiziana Nasdaq. Investors will get their shares soon, if investors broker allows then they can buy and sell, depending on each brokers internal policy in regards to Tiziana Nasdaq re-listing, once the Nasdaq shares are in investors account. One Nasdaq share for every two UK shares held.
I have very clearly and openly expressed the concerns, dismay, anger, disappointment, sadness, fears and thoughts of investors re: Tiziana is a scam, BoD are liars, been taken for a ride, not able to keep to timelines which have gone completely off course, a life style company interested in only themselves, BoD being more interested in ramping the company when a placing was needed, promises made by Kunwar and GC in investor presentations that have not been kept or materialized.
Her reaction tone of voice and reply was one of concern, sadness and understanding investors thoughts and frustrations. Hanna was apologizing and very sincere in her replies for the current resentment thoughts and fears investors have. I asked and she responded by saying that the sentiment of investors will be passed onto the BoD. Hanna insisted that everything possible is being done to move things forward under the ‘legal rules of being a listed company and under the past/current covid climate’. Everyone within Tiziana, including Hanna, has a vested interest in seeing the company accomplish its strategy and goals, as they are also share holders.
I can honestly say Hanna listened to everything I had to say, never disagreed once, was sincere and apologetic in her responses, very determined to see things get moving, and Hanna reassured me on numerous occasions that things are moving in the back ground as quickly as possible and soon the Accustem scheme will be published and voting on the scheme will commence, this all has to be done and will be done under legal restrictions and responsibility apposed on Tiziana as a listed company.
I thank Hanna for her time and responses to all of my questions and concerns, ever so helpful sincere and apologetic not only to me but all investors.