An explanation about today's press release:
So the press release is good news, but it kind of remains unclear what markets open up for Sorrento immediately. Let's try to understand what the PR is saying.
The PR mentions "enables Sorrento to sell this device in all territories that accept the Qarad EC-Rep (Belgium) CE Mark for commercialization".
So what does that mean?
Well, receiving the CE mark is an excellent start, but it isn't enough to simplt sell any product anywhere in Europe. The CE mark is a first and necessary step, but of course, then each product has specifics it must comply with. Compliance for selling TV's isn't the same as medical devices, although both need the CE mark, they then need other different regulatory processes.
In the case of Sorrento, it needs two things basically: an external company that performs a "conformity assesment" of the product. This company, so to speak, gives the "ok" for the product. Sometimes, depending on each country, more than one conformity assesment is needed.
The other thing Sorrento needs is a Authorised Representative. Since Sorrento isn't a European company and doesn't have a European presence, it needs a company based in the European Union to act as a bridge between Sorrento and the national authorities in Europe.
That is basically what Qarad is, it's Sorrento's representative in Europe. Right now, we do not know if Qarad, which is based in Belgium, will be able to set Sorrento up for sales of covi-stix throughout Europe, but at least SRNE has a representative, and that is what it needs.
So this is good news, but we still need to wait and see. Maybe in the upcoming days or weeks we will receive confirmation about countries that have opened up for covistix. The CE mark by itself is not yet enough per-se.
This is good news and too bad it didn't reflect on the price. Hopefully once Sorrento strikes distribution deals, that will have an impact on price.
Also, keep in mind, there are more than 300 approved covid testing devices in Europe. So we have a lot of competition. Covistix is very accurate so hopefully that will give us some edge.
