As we all are aware, it has been publicised to the market that CE Mark would be achieved by end of Q3 2015, however the progress, the process or the filing date has not been communicated.
On this basis, I took it upon myself to call the company hoping to speak to the poor soul designated to handle investor relations and SH queries. I was advised that “everyone was in a meeting “and to give my contact details and someone would get back to me (very promising).
To my pleasure, I received a call back directly Daniel Kenny himself who seemed more than happy to discuss the progress of the company, specifically the progress of the CE mark filing and when the news on the CE Mark outcome can be expected, and any other questions I had.
Dan has advised that their submission of the CE Mark, to British Standards Institute (who issued ISO cert), has been drip fed to BSI throughout the course of this year. He advised that this is because this approach has proven to be the more pragmatic approach in his experience as opposed to “dropping a 1000-page document on their door step”. Further, he advised that the progress of their CE mark application was currently at the stage of them working through discussions on any queries BSI might have.
Dan verbalised multiple times that we “extremely confident” that they would recieve news of a CE Mark achievement in September. I suspect that this timeline is based on the fact all filings have been made to BSI and that the process is just currently being massaged. Dan did not confirm whether a 90 day procedure or expedited 45 day procedure was taking place.
He expressed that he was very aware of managing shareholders expectations around this date and that this the expected September announcement factors a margin of error in the scenario that CE mark was delayed for whatever reason (which was my primary concern - too often CEOs and BODs are all too enthusiastic about promising the world to the SHs which only results in expectations not being met and the SP getting pummelled). I stress again that he could articulate enough how extremely positive he felt that he would be making a positive announcement in September regarding CE Mark.
He also stressed that the current cash position provided the company with ample funds to see the through to Q1 2017 as such there would be no need for a capital raising in the near future (he alluded to late 2016 post CE mark and FDA approval). He said that their only costs were salary and wages, and that CE mark has been paid for in full and further research and development has been postponed till after CE mark as the primary goal of the company is in obtaining a license so as to be able to generate revenues.
The call gave me a great boost in confidence on our CE Mark progress. To be honest, Dan seems like absolutely top CEO and great bloke all in all. He has really turned our company around and provides us with a real commercial edge that seemed to be lacking before his arrival. He mentioned he has all the time in the world to talk shop with SHs so if this post doesn’t give you goose bumps thinking about our impending CE mark approval, then by all means give the co a call and ask for a chat.
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