Ann: Positive CE Mark Status Report, page-91

There are two definite facts - the ‘honeycomb’ device within which the radiotherapy works - has been filled with other medicines and used within thousands of patients who have had the device inserted in their eye can testify to this. (Eyepoint Pharma) has 4 FDA approvals, and USA Medicare Pass through status and permanent J Codes attest to this. These are facts. Radiotherapy is an accepted treatment regime, Radiotherapy does Its effective role during cell replication. Despite wide acceptance and use - Beam radiotherapy has two huge drawbacks, hitting healthy tissue on the entry and only being available temporarily (ie not during all cell replications). Logically and rationally based upon these facts it can be deduced that two proven products working together will produce the results. The current studies indicate - approx 25% conversion to resection and a high % of the conversion cases with clear margins & pain relief looks to be much much better than SABR (studies indicating 4.8% chance of conversion to re-section). From a human perspective a one off endoscope with efficacy for 3 months as opposed to daily visits for periods of weeks to hospital to receive radiotherapy - with less time at home. The conviction is that thousands of patients will have a chance at the 5 years survival co-hort as opposed to an extra 2-3 weeks suffering with a combination of 5 different chemotherapies. It is possible that post approval the numbers of conversion to resection are greater than 25% and that this may become a frontline therapy. The study results, while not huge patient numbers, are entirely in line with the logical conclusions that can be drawn from the evidence. The issues of regulatory pathways, reimbursements ect does need patience from the investor community and supportive investors