Viel Spaß beim lesen.
(...)
With that, I'd like to now turn the call over to Hakan.
Hakan S. Edstrom - President, Chief Operating Officer and Director
Thank you, Matt, and good afternoon. Since our last call in early November, we have completed the recruitment phase for both trials in the Affinity program and this achieving this major milestone. The clinical and medical teams, together with our contract research organizations, have been intensely focused on the execution of our trials. The monitoring of patients at the clinical site is all in accordance with the study protocols, MannKind's operating procedures and good clinical practice.
As a reminder, we are running 2 key Phase III studies. The first of these studies, study 171, is an open label study in patients with type 1 diabetes. The study includes a run-in period, during which all patients are optimized on their basal insulin, a total of 518 patients were randomized to 1 of the 3 treatment groups for the mealtime insulin: a control group in which patients utilize injected rapid-acting insulin analogues; the AFREZZA using the MedTone inhaler; or AFREZZA using the generation 2 inhaler.
After initial trial with mealtime inhalation optimization period, there is a subsequent 12-week stable insulin dosing period. The primary objective is to establish noninferiority between rapid-acting analogues and generation 2 treatment groups and also competitive safety profile of the AFREZZA treatment groups with the 2 devices.
The other Phase III study, the 175, assesses the addition of AFREZZA using the generation 2 inhaler to patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or a third oral medication. Again, after run-in period, during which the patients stabilized their oral medication, a total of 354 patients were randomized to additional treatment with AFREZZA or to a placebo group using only the Technosphere inhalation powder. This study also includes the titration period, followed by a 12-week evaluation period to assess the H1c -- HA1c (sic) [HbA1c] levels, other secondary parameters and safety.
Randomization was complete for both trials in November of last year, so the individual patient visit for the remainder of the trial are now visible and can be tracked and managed in real time by both the clinical site and the MannKind monitors. Our teams are now managing patients through the trials patient by patient, and the last patient last visit continues to be on track to May and June, respectively, on 2013. The operational plan for rapid database lock and the production of final tables, figures and listings is in place, and we expect to share the key trial results with you sometime in mid-August.
We have also submitted a written request this month to inform the FDA of our intention to submit a Class 2 resubmission in 2013. The purpose of this presubmission meeting is to seek concurrence with the agency on the content and the format of the resubmission. The FDA has already informed us that it will provide a written response to a briefing package in March.
We are targeting to resubmit the AFREZZA NDA between late September and early October, and we expect a 6-month review. All other activities that support the resubmission are well underway and progressing according to plan. We remind you that the amount of data and supporting information including tables, graphs and listings for the resubmission is extensive. A detailed operational plan outlining all of the activities required for the resubmission is in execution, and we remain fully committed to meet the 2013 timeline.
aus:
http://seekingalpha.com/article/...2-results-earnings-call-transcript
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Beste Grüsse,
Oki-Wan 2.0
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