TSO3* (TOS : TSX : $1.04)
Net Change: 0.12, % Change: 13.04%, Volume: 312,772
Finally a timeline. Shares of TSO3 jumped after the company announced that its new simplified filing to the US regulatory agency for clearance to commercialize the STERIZONE(R) 125L+ Sterilizer in the U.S. market has passed the acceptance review step, ensuring that the file is administratively complete as per the Agency's requirements. The Agency has granted TSO3's file a 510(k) number and will now initiate the "substantive review" process. As per the Agency's most recent guidelines, the Agency is now targeting a response within 60 days of the filing, with maximum agency clock of 90 days. Within the guideline the company has 180 days total clock to respond to Agency questions. Canaccord Genuity Sustainability Analyst Sara Elford noted that the core tenets of her investment thesis remain intact: 1) technology platform is game changing and applicable across multiple products and end markets; 2) business model is excellent (very healthy, high margin recurring revenue from captivconsumable sales based on the in-use installed base); 3) cash balance is sufficient to fund recent burn rate well into 2014; 4) U.S. clearance remains a matter of when and not if, in our view; and 5) we think the probability is very high that TSO3 will become an acquisition target following a successful FDA outcome.