Tardugno.......ODAC might be unnecessary
Michael H. Tardugno - President, Chief Executive Officer & Director
Let me just go beyond that, we do have a great deal of experience in filing NDAs from an executive level, from a hands on level, from writing documents, various sections of the documents. But we were also smart enough to know it is an evolving market. We have multiple consultants who are very close to the FDA in terms of current filings. One of which has an expertise in publishing and submitting data through this electronic common technical document approach. The other consultant has a great deal of experience in oncology, in messaging and positioning, and certainly in dealing with ODAC which we don’t expect will be a requirement for approval of ThermoDox but certainly we’re preparing for it.
