Peter Richardson - Corporate Vice President, Chief Scientific Officer
Thank you Hakan and good morning. As Hakan has indicated, the past quarter has indeed bee a very busy time to the scientific and regulatory team at Mannkind, as we successfully filed our response to the questions raised by the FDA in the complete response letter.
To remind you, there were three substantive areas for which the agency raised questions; clinical utility, or where does the project and the product fit into the therapeutic armamentarium with patients with diabetes; the assay methodology used in our study to demonstrate bio equivalency of the inhaler used in our pivotal clinical studies and that to me marketed; and finally, technical aspects of the requirements of the device, such as how often is it changed and how we mark the amount of drug and identify [ph] each cartridge.
As we indicated to you in our previous updates, we are confident that we will be able to address these on the basis of data we already had available, or in the process of generating as part of our previously agreed development of our next generation device, formerly known internally as Dreamboat.
http://seekingalpha.com/article/218105-mannkind-corp-q2-2010-earnings-call-transcript?find=crl&all=false
