OT reply to Ezra at Yahoo
posted on
Jun 11, 2012 10:54AM
Edit this title from the Fast Facts Section
Ezra,
They may still be there.Last year it appeared that they wouldn't be there...
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_M/threadview?bn=25210&tid=205745&mid=205779
But they were...
"Mannkind aiming for a more comfortable, convenient solution for patients
Although it has run into its share of problems with the regulatory process, Mannkind’s Afrezza continued to make an appearance at the ADA this year. Mannkind presented several abstracts evaluating its inhaled insulin, among them a pooled cardiovascular safety analysis and a thorough QTc study, which reported no adverse cardiac effect of therapeutic and supratherapeutic doses of Afrezza. The product has been the subject of over 50 clinical trials and is the last active clinical program for an inhaled insulin product, thanks largely to infusion of funds from the company’s founder. The company switched to a substantially new delivery device following their initial NDA submission and, understandably, ran into regulatory roadblocks. The FDA has twice rejected Mannkind’s application for approval, requiring additional trials, and other information regarding equivalency of the newer delivery technology. Although theoretically enticing for rapid onset of action, inhaled insulin products have not yet panned out and one wonders about Afrezza. Mannkind recently stated that following their May 4, 2011 End-of-Review meeting with the FDA they are prioritizing their clinical efforts for required Phase III studies with the new device (one in patients with Type 1 and one in patients with Type 2) that will also be able to assess in a head-to-head manner the pulmonary safety of the two delivery devices."
http://www.pharma-share.com/news-ada-2011-building-insulin-therapy