Mologic CE marked AffiDX for professional use, CE mark with #avct not Med19 AffiDX solely an avct brand. Med19 CE self use mark for Meduflow, EU CE mark solely Med19’s for Meduflow not avct. Professional & self use CE marks differ in use, both need separate CE marks.
1/23
Med19 have done all the hard work re: lay user study, filing all docs for CE mark for self use with EU notified body, as well as the money and time spent in obtaining CE self use mark for Meduflow. Med19 will be looking to keep and make a serious return on their investment
2/23
I suspect main points under license agreement between #avct Med19 would be:- use Affimer IP in Meduflow, Med19 achieve minimum yearly sale targets, which global territories (if not covering all world), royalty % per test sold, duration of license agreement,
continued…
3/23
permitted use of #avct brand name, do Med19 get first refusal on future tests avct produce…I’d expect so.
Med19 have exclusive ‘Business to Customer’ deal so Med19 dictated what happens on this front, within terms of license deal with avct. Med19 will publicise granted CE mark through global public news media outlets. I suspect Med19 will give #avct permission to do the same.
5/23
Why AS has repeatedly said he cant say anything on Med19 deal, must respect terms set out. License deal is a binding contract with all detailed terms+conditions set out, and adhered to by both parties. For Med19 & avact CE mark will be a seminal point to publicly shout about 6/23
AffiDX is manufaxed by GAD, soon #ABDX if not already. #avct test for global B2B cld be also manufaxed in EU and other territories. AS has stated he has established further global manufax capacity and distributors in EU and APAC, when they’re needed they will be turned on.
7/23
@boy_cellar APAC manufax answer cld be in his tweet. If I was #avct Med19, together I’d work on securing extra global manufax capacity for B2B+B2C. AS said: in talks with over seas manufax for 1 mill tests per day, avct will go through Tech Transfer
Med19 are manufax+distributors+ online sales Co. They’re more than experienced capable self sufficient in carrying forward consumer sales within EU+further afield🌍. Med19 through Boohoo Co, will have a detailed blueprint & infrastructure template ready to sell to customers
9/23
#avct have no experience in Business to Customer area let alone resources, man power, time, set up, logistics. B2C expertise is a complete different business model/beast to what #avct are accustomed to. However avacta have vast experience dealing with Business to Business.
10/23
Been told by Med19 (convo) globally they are working with distributors an looking for more. Med19 owners Kamani & Richards vast expertise comes from starting Boohoo in 2006 developing manufax partners distribution lines online sales. Boohoo is now a multi bill £ brand/Co.
11/23
Christian Stephenson Med19 Chief Development Officer “we are upto supply chain of 100 million+ per month can scale this to significant vol” more than 100+mil a month. No one says upto 100+mill tests for no reason other than ‘foreseen global demand’ 100+ mill is scaled into
12/23
Med19 website it does say manufax capacity can ramp up to 50 mil tests. Either way looking at 20 50 or 100 mil tests per month, with those huge manufax numbers being spoken of Med19 are ambitious prepared determined to be manufacturing 20 50 or 100 mil tests per month #avct
13/23
So far 20 million has been spent on Med19 Manufax factory, not small change by any means. I would expect Med19 to further inject more cash to the manufax side of the business to build in more infrastructure I.e. machinery operations account sales and management staff
With such a unique opportunity within the Covid space, who wouldn’t be eager hungry greedy, have the foresight to make hundreds of millions if not billions in revenue €£$. Also means #avct Med19 taking a huge share of the new future burgeoning self use diagnostics market.
15/23
No business or brand builds success on IP pipelines, obtains CE/global certificates and revenue to then transfer Co/brand to another Co. Only unless a buying bid multiple times of value+revenues was on offer. Cant see #avct Med19 doin this anytime soon even with each other
16/23
Personally think #avct Med19 are working closely with each other, hand in hand, scratching each others back, cozy’d up in bed. Both are hugely determined to get this right from the get go. Relationship they have is unique, to some degree looking after one anothers interest
17/23
Both #avct and Med19 are eyeing up to take a huge chunk of B2B and B2C global markets for self use diagnosis. This doesn’t stop at the foot steps of Covid, but goes onto much wider platform areas of self diagnosis like countless other pandemics, illnesses, health problems
18/23
#avct Med19 are going to surprise many as to what both have rolled up their sleeves+reveal. Market wont see half the deals/territories/sales & revenues yet to come, as well as future self use tests developed for different illnesses+health probs avacta Med19 have plans for
19/23
Why did Med19 get involved with #avct. For Med19 Its all about avacta’s IP Affimers, the endless possibilities of those Affimers to be made into self use diagnostic tests for a huge array of illnesses. All things go to plan I can see Med19 floating on stock market one day.
20/23
#avct are the brains behind the pipeline of IP secured biotech, including Affimers. Med19 is the titanic ship and global launch pad for avacta Affimers (possibly more biotech pipelines). Both Co’s clearly understand and appreciate what unique value each bring to the table.
21/23
#avct Med19 clearly understand appreciate what value each bring to the table. Watch them become colossal giants in coming years if not sooner, once in a life time unique story opportunity to be apart of. Calculated evidence based risk = rewards. Avct Med19 many PIs get this 22/23
‘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.