Legume
'Since a recommendation wasn't made, one must then conclude the application as made was rejected. '
Have to take issue with this assertion. CE applications are never rejected as such. As you stated the NB will continue to work with the applicant. In my view until
A) it is granted
B) the applicant gives up as being to difficult
C) the applicant runs out of funds to continue
D) the applicant decides to go with an 'easier' NB.
As long as an applicant has deep pockets and time on their side it is almost impossible for an application to be rejected. OSL will probably get the CE mark sooner, or later.
They may even get an IDE, and then the hard work really starts,
Ann: OncoSil Medical CE Mark Update, page-77
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