Dex Com CEO Andy Rasdal presented at Lazard's meeting today in NY. Key takeaways:
1) They will their STS pivotal trial study published in Diabetes Care in Jan 2006 - this will be the second Diabetes Care publication for this young company - very impressive - and will be the first prospective continuous trial published, full stop. 2) It is too soon to say conclusively (probably) but it's looking less and less like a panel meeting will be required for the STS - we think, more to the point, that even if a panel meeting is required, we really can't imagine that approval wouldn't be granted. Although a panel meeting would delay a launch, it would also probably generate some great media; 3) Dex Com has 18 patient-years of data, which we understand translates to use in 500-600 patients; 4) The company says they have HCP training to less than one hour and patient training to less than half an hour - "easy to teach and learn" is key, and this is quite something if it holds; and 5) Their next submission, the 7-day sensor, is done and ready to be submitted; to boot, the company was clear that replacement claim labeling is next - on this front, Dex Com looks to be in discussions with the FDA and clinicians on the most appropriate study design. Feasibility studies were initiated two weeks ago. Serious investment looks to be going into this, which seems very appropriate.
All in all, looks to be very strong momentum and we would expect an approval in the not too distant future. Reimbursement will be the next hurdle and we would imagine all the players would benefit from Medtronic's investments on this front. We'll be staying tuned ...
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