Question-and-Answer Session
Operator
Thank you very much. (Operator instructions) Your first question comes from the line of Imron Zafar with Deutsche Bank. Please proceed.
Imron Zafar – Deutsche Bank
Hi, good afternoon. Thanks for taking my questions. My first question is on the injectable formulation. Sam can you just talk to us what your latest thinking is on the pivotal trial strategy there. Have you had any discussions with either FDA or the European regulators or even your advisory committee?
Samuel Lynch
Well we certainly have had discussions with our scientific advisory board and our clinical advisory board and with our – some of our investigators in our ongoing clinical trials. We have not yet had any discussions with the FDA or any other regulatory body per se. We will look at having those discussions probably in the first half of next year. We’re focused Imron currently on completing enrollment in the ongoing pivotal trials making sure that we have excellent follow up and tracking of those patients so that we maximize our opportunity for success with our ongoing pivotal trials. And frankly not distract any regulatory body right at this critical juncture with additional product candidates or additional filings. So again with our two PMA modules going in next spring for Augment, again we’re focused on preparing those and on focusing our discussions with the FDA on those modules. So we’re totally focused on maximizing our opportunity for success of Augment at this point, and well certainly having ongoing discussions with clinicians relative to the AIBG formulation, I wouldn’t expect that we would initiative substantially like another pivotal trial program any time in the near future for that product candidate.
Imron Zafar – Deutsche Bank
Okay. And then in talking about your European trial you mentioned that those data you gather from the European study would be used for regulatory filings in other markets. Can you be a little more specific on what other geographies you’re looking at?
Samuel Lynch
Well as you know, I’m sure we’re taking a global approach to product development with trials not only in the U.S. and Canada but in several countries in Europe through – for – as part of that EU study of course then in Sweden as well and we think that collectively that data from the North American study as well as the EU study should be sufficient for approval of Augment worldwide.
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