Eye on the prize, page-16

Mangy, your post is a little misleading, the following is a history of some of the clinical trials that have already taken place. There will be a confirmatory trial after the consultative process for FDA approval of the system incorporating the sheath. That approval is the one that Optiscan and consultants are working on atm and scheduled for later this year. We should get more on this from the promised June Qtr update. The process design needs to be ticked off by the FDA otherwise any trial on the way to approval runs the risk of not being recognised. I think we have wasted enough time not to take any risk of that happening!!

"The initial critical path item is the engagement of our regulatory consultant, which will lead to direct liaison with the FDA and will refine the final steps to completion of the neurosurgery
system development. This engagement has commenced and, among other things, will address
two critical issues:
• Exact study requirements around the integration of the disposable sheath into the larger
neurosurgery live imaging system; and
• The scope and timing of design transfer into production.
The outcome of the regulatory consultant process will clarify both the timing and cost of these
remaining steps of the neurosurgery system development. As commented above, we expect this product development to be complete in the December half this year and we will report the​

outcomes of the consultation process in the June quarter."

From the Chairmans address at the 2013 AGM talking about the sheath.

"I am however pleased with the point we have now reached with this final component which is now only subject to small manufacturing advancement and sterility and packaging related testing. The result is an elegant, high quality disposable sterility solution for our rigid neurosurgery endomicroscopy systems. Once this final testing is complete, a further small human trial will be conducted after which regulatory submission will be made."

Some of the trials already taken place from 2009
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https://clinicaltrials.gov/ct2/show/record/NCT00949793?term=zeiss endomicroscopy&rank=1

http://www.ncbi.nlm.nih.gov/pubmed/20087141

http://www.ncbi.nlm.nih.gov/pubmed/21336204

http://www.ncbi.nlm.nih.gov/pubmed/22283191

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