The possibility of CE approval significantly decreases with every passing day. BSI are rigourously enforcing the recently revised MEDDEV 2.7.1 Rev 4, Clinical Evidence requirements (June 2016). Think Sydney parking attendant rigour. IMO CE approval is impossible in the absence of successful IDE data.
Re: IDE, it's unregistered on clinicaltrials.gov to date. Indicative no site is up and approved yet. Interestingly I have just attempted to achieve IDE approval for a client using OncoSil's reported "run-in" strategy. I have been assured by the FDA that no such "run-in" approval pathway exists. Rather, the results of a pilot study are required to be resubmitted to support FDA approval of a subsequent pivotal IDE study.
I can only conclude that OncoSil's IDE approval is for a pilot study of 20 patients.
From the ANNS, Denial Kenny's starting salary was $200,000k p.a. ex super, ex bonus, in November 2014. Per the 2016 AR he earned a total of $653,073. His tranche 4 bonus is due in Nov 2017, having served 3 years. Will Denial make it? The recently departed Martin Rogers has also cashed in subtantially.
How are the shareholders going? They seem a little ticked off and a lot duped.
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