Bob,we're talking about the annual shareholders meeting and that's not until the 23rd.The trial should be done around that time.
Al :
(Feb 11,2013)
This study protocol was generated in close collaboration with the FDA. After run-in period of 4 weeks for Affinity 1 and 6 for Affinity 2, there are 12 weeks of titration, 12 weeks of treatment and a 4-week follow-up after completion of the therapy. Affinity 1 will thus complete in late May and Affinity 2 in mid-June. Data log and preparation of the resubmission will take at least about 3 months, so as Hakan noted, the filing is anticipated in late September, early October. We should be able to release the Affinity trial results in August.
We had reported that for these trials, the FDA wanted to include patients with A1Cs averaging between 8% and 8.5%. Such a high average A1C required of some patients at baseline A1C of 10% or more. Those high initial A1Cs will enable a patient to show truly substantial lowering, but as the premier centers are conducting these trials, there are not many such poorly controlled patients. To satisfy that baseline and ensure that we have more than 399 and 246 completers respectively for the 2 studies, we screened 1,402 patients for Affinity 1 and 1,381 for Affinity 2. That was a major challenge and took more time but was successfully achieved.
One of our concerns had been potential patient dropout because of the substantial demands on the patients in those trials. We therefore overenrolled to better ensure that we have adequate statistical power. We are pleased to report that both studies are tracking well. At this point, we are quite confident that the trial will be completed as scheduled with more than enough patients. As of last week, 297 patients already completed the treatment phase for Affinity 1, that's about almost 75% of the total, and 167 for Affinity 2 or approximately 2/3 -- a little over 2/3 of the target.
http://seekingalpha.com/article/1173611-mannkind-management-discusses-q4-2012-results-earnings-call-transcript?find=complete&all=false
