If you're right, and I did note that on the individual's biography on the OSL website that her career highlights are listed as filings at Sirtex in couple of South American countries but there is no mention of previous CE experience, then is it not an act of some folly to have the most senior regulatory person in any company operating at a VP level without any prior CE experience, when a company's critical deliverable and possible future is based on CE marking? My experience of other life sciences companies is that a person at this level would have been expected to be held accountable for regulatory performance and ultimate regulatory success, so as a shareholder it is germane to ask, if the CE does get approved, exactly how much time (and possible revenue) may have been lost due to the lack of requisite critical expertise.
Cutebaby- I have already provided a citation in the other post to the relevant paper which provides much detail on Nanoknife and other directed therapies in locally advanced pancreatic cancer. I don't wish to be harsh but I'm sure you are more than capable of doing the same research that I have done. It is Angiodynamics that manufactures the IRE (Nanoknife) equipment and is indeed CE marked. The point of my highlighting this is that it is clear there are other competing technologies, some with reasonable experience of use already in the marketplace, others in advanced clinical trials. I can't comment on the credentials of the two Bell Potter analysts you cite or the thoroughness of their enquiries. I would recommend though that if you plan to remain a holder of stock in a company that is working in the complex field of pancreatic cancer, your consumption of facts in relation to this disease should probably expand beyond ABC and the Age.
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