Downrampers Fail, page-9

I've seen too much over the last couple of years to expect a binary outcome. For example all past medical device applications at the EMA have been approved at the 210 day point or earlier since 210 days was legislated. However, there is no evidence that any company has been asked to delay their submission to ensure the 210 day timetable is complied with. There also seems to be built into the timetable the possibility of a further list of outstanding issues with the potential for these to be answered by way of oral submissions to the committee.

Furthermore, the EMA does not regulate medical devices but only issues opinions that are then acted upon by the notified body (BSI) so the potential exists for EMA to issue a negative opinion that is disregarded by BSI. There is also the possibility that EMA identifies a number of issues and says that until these issues are rectified they will not issue a positive opinion.

Early on in the process I would have pointed to the historical evidence and said that the data indicates a positive opinion will be granted. Now, having been burnt by time regarding the VG pathway and by completely unexpected results re other bio-medical shares, I am not prepared to predict what will happen in February. Of course I still remain hopeful as the product appears to have an enormous potential.

Rev