CE Marking substatively complete

What does this mean? Well I gave OCC a call and found out.

There are several stages of the CE marking approval process, and what OCC have announced is that the "audit and review" stage, whereby data requests are made by the CE marking panel (across multiple facets including manufacturing, technical, safety etc) and OCC respond and provide the requested data. This stage typically can take longer than expected, and it has proved the case. However this hurdle has now been passed, and OCC have advised that they have advanced to the next and final stage, which is approval committee.

So in summary, the detailed review has been complete. And the submission is basically sitting at the final committee to see if they have any further questions or if they are happy to approve. Having the application pass the review and audit stage, OCC assume that all the questions and issues have been resolved and final approval should hopefully be smooth.

I was also told that the J&J announcement in January is probably more significant than the market has appreciated. J&J, the largest pharma in the world in terms of revenue, chose Orthocell as their FIRST investment into the cell therapy. Yes that is right, after J&J conducted their due diligence (which I was told to be extremely detailed), J&J advised OCC that they had pass their D&D and were happy to invest.

Now I don't know about you, but if J&J start venturing into cell therapy through OCC's technology ... the sky is the limit!

Anyhow after the call with OCC, I felt very confident that CE marking is only a matter of time. And management feel that after a 7 year development, they are more than comfortable with a few extra months of waiting.

Good luck all! needless to say, I topped up this morning.