Read the CE mark update Ann... it's actually a joke.
Probably need to have the centres signed up before ou can recruit the patients...
"The 20 patient supplemental data request from BSI is consistent with the request received from the US FDA prior to granting an IDE in July 2016"....so where's that data?
"The company is well positioned to supply the supplemental data from its global pancreatic clinical study programme"....with no patients recruited.
"Based on the curren recruitment projections and data follow up requirements the company expects to provide the supplemental data by the end of Q3 2017"
So 19 patients to go - 6 months to recruit, perform the study, analyse, culminate and send he data off...
Dreaming!!
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