#AVCT Spoke to someone at Med19 today for 1hr 46min. Not give any detailed info. Wat I will say is: HUA in very final stages, infact very little else to do. Everything asked for has been submitted, even if EU asked for it twice its been given (if u understand wat Im implying) 1/9 Image
Global demand is huge, getting calls from global govs/busi/high caliber distributors-business men. Med19 have orders, ready to take more orders soon as HUA is given. Affidx recognized as a gold standard reliable test, easy to use. Med19 working with global distributors 2/9
Med19 ready 2 scale up and sell multiple millions of lft’s, for global busi/gov/consumer orders. All Affidx components in stock for first batch orders. Product box/packaging/art work/instructions for consumer use almost ready, proof readin sign off needed by EU HUA body 3/9
demand for Affidx is global from every corner of world, once EU HUA is given (and it will be given very soon) because med19/avacta will have all certificates/lab data/ce marks etc in place, getting HUA from apac/other countries will be a far more easier paper exercise 4/9
EU HUA body will have done all the hard work/due diligence for affidx to obtain HUA. This will then give Affidx the gold standard pass (given by the EU) for other countries to confidently and with ease give Med19/Affidx HUA 5/9
Affidx is being sought for by global gov entities, huge busi industries. Most countries asking for Affidx stock (in huge quantities) have stated they’re fed up of unreliable Chinese tests, and see Affidx as a gold standard reliable lft that can quickly be modified to variants 6/9
high caliber distributors/top business men/businesses in huge sectors/gov departments globally are ready to ink contracts once HUA is given. It’s not an if anymore, its very soon. Demand is coming to avacta’s table not avacta going out to create demand 7/9
Med19/avacta have a stategy in place working away in the back ground, also from convo I got the feeling that Med19 will be going above and beyond to supply avacta with as much manufax capacity as they need to supply govs/business/consumers globally without hesitation 8/9
Convo was very in-depth, I will not disclose numbers or countries where demand is coming from, AS has already hinted. What I will say is demand is huge, Med19 are ready with stock components, marketing PR material and manufax in multi millions. Demand is sought for, inbound 9/9

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More from @jaykay_jayk

25 Nov
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
Read 24 tweets
19 Nov
‘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.

3/16
Read 15 tweets

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