Neovasc Inc (NVCN)

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“guidance outlines various program options to better address device development topics as they arise, such as sprint discussions—meetings between the FDA and sponsors who need timely resolution of specific issues such as testing protocols—requests for feedback on a data development plan and requests for clinical protocol agreements. “

Basically this news doesn’t mean shit. The reason is because....... “Since the Breakthrough Devices Program was authorized in late 2016 and added to the 21st Century Cures Act, a total of 110 devices have received the designation and eight have received marketing authorization.”

That’s to say only 4 companies get approval every year. NVCN only enrolled 8 months ago. 10/10/2018.