Ann: CE Mark Update, page-42

ASIC needs to take good look at OSL. Here's a few starters:
- The original prospectus stated that funds raised would be used to commence a 'Registration Study' to support regulatory approval. Some four years later and $20m + raised, no such study commenced and not one patient recruited.
- Some bright spark on the board suggested that a Registration Study wasn't needed and that CE Mark approval could be gained based on the original Psivida study performed on some 30 patients a decade ago.
- This shockingly bad decision clearly caused internal turmoil as the Managing Director, Chairman and Senior Executives either resigned or were sacked.
- At the same time there was an article published by The Long Tail making various allegations against the company and its dealings with the CE Mark body claiming to be sourced from an internal whistleblower within the company. The company took legal action to have the article taken down but plenty of investors had read it and expressed concern. As a shareholder, it prompted me to sell out.
- The company then embarked on a positive PR campaign maintaining that a CE Mark approval was not only extremely likely, but following 'fast track' approval status, now within weeks. That was almost two years ago. The only updates they provided were that approval would be very soon and that they were building a sales force awaiting the imminent approval. Investors began to smell a rat as the months went by and the SP slowly drifted from 26c to the lows of today. Regal Fund must be so angry having paid 22c on the back of these questionable statements from the company.
- Now the company puts out one of the strangest announcements I have ever read: CE Mark conditional approval. There is no such thing. Never in the history of biotech has a company announced a CE Mark conditional approval (Google it, you'll find nothing). It's been rejected! 'Go off and do the study you said you were going to do four years ago', was basically their response.

Here's the question for ASIC to ask the company. WHEN DID THE COMPANY FIRST BECOME 'AWARE' OF THE CE MARK CONDITIONAL APPROVAL (IE: REJECTION)? I suspect the answer is one that will shock the whole biotechnology sector and lead to a shareholder class action similar to Sirtex.