These distributor networks are an important first
Post# of 11803
(Total Views: 477)
Posted On: 10/28/2020 2:19:51 PM
These distributor networks are an important first step. I would think that the company expects a CE Mark sooner than the FDA EUA, so having overseas distribution set up ahead of time will give them a big head start.
Of course, it would be a huge benefit for DECN to obtain the FDA EUA around the same time as the CE Mark. That would explain the talks with US based distributors. With a CE Mark alone I believe DECN would be approached by quite a few manufacturing partners to help fill all the orders. Throw in an EUA from the FDA and it's balls to the wall.
By the sounds of it, the testing for GenViro! Saliva is going well. That's great news. And, as we all know, the testing is being performed by an "FDA and CLIA certified US-based testing partner". This is an important point. These guys are the real deal.
Of course, it would be a huge benefit for DECN to obtain the FDA EUA around the same time as the CE Mark. That would explain the talks with US based distributors. With a CE Mark alone I believe DECN would be approached by quite a few manufacturing partners to help fill all the orders. Throw in an EUA from the FDA and it's balls to the wall.
By the sounds of it, the testing for GenViro! Saliva is going well. That's great news. And, as we all know, the testing is being performed by an "FDA and CLIA certified US-based testing partner". This is an important point. These guys are the real deal.
Quote:
Late last month the company announced it had signed an agreement with an FDA and CLIA certified US-based testing partner to undertake a feasibility study together with required testing for FDA EUA and European Union CE Mark certification as well as with the Russian Federation for submission of the GenViro! Covid-19 Saliva Swift Kit. The lab results will be included in DECN's upcoming FDA EUA applications which are expected to be filed in Q4 2020. The company plans for parallel applications with the EU and Russian Federation, as it continues its international efforts to make its detection technology available globally.
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