Monday, November 13, 2017 8:50:38 PM
From what I have read about the process of reclassification of a device it comes after the safety trials. A company submits evidence of efficacy and safety when applies for De Novo.
So if they have not likely applied for designation yet why would they be on the SRO list.
The SRO list is for companies selling products regulated by the FDA, about to sell products regulated by the FDA, or running clinicals regulated by FDA.
I'm starting to think them being on the SRO list has to do with the Cytotronics platform. That is where they could actually produce a sellable product right now and the company projected sales from the Cytotronics platform the second half of 2017.
If this is the case and they have lined up a revenue stream through this platform it will change the whole dynamics of the company.
Ultimately it's just a waiting game but I like to speculate and it has served me well so far.
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