Monday, August 01, 2016 4:29:00 PM
For those that are new, the CE mark is a designation that will allow them to sell AC5 throughout the European community. It is a faster path of approval than the FDA in the US, because the US requires a longer and more substantive clinical trial process.
By obtaining the CE mark in Europe, Arch can start deriving revenues that can help pay for the FDA approval pathway.
The biggest issue right now in this stock and why everyone is at odds is that we dont know if the company is going to put out a press release about the results of the human trial prior to submitting for the CE Mark or just wait to let shareholders know once a decision by the European Authority is made.
The news that I and so many others who have been in the stock have been waiting for is how the trial went and if they are confident that the results are in order to obtain approval.
That kind of positive news should be the catalyst to 80-150% gains from current price levels.
Hope that clarifies things.
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