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Post by vdhingra on Jan 31, 2014 12:52:57 GMT -5
Dose anyone have any insight into how MNKD answered the 'clinical utility' question from the first CRL (personally, I'm not even sure what the FDA was asking: AF is parandial insulin and should be used as such, and that's the clinical utility).
But anybody know how MNKD specifically answered that question (seemingly by second CRL, it was no longer a concern).
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Post by brentie on Jan 31, 2014 13:17:19 GMT -5
Dose anyone have any insight into how MNKD answered the 'clinical utility' question from the first CRL (personally, I'm not even sure what the FDA was asking: AF is parandial insulin and should be used as such, and that's the clinical utility). But anybody know how MNKD specifically answered that question (seemingly by second CRL, it was no longer a concern). We are available to do this because of the major improvement in the device manufacture ability and the significant reduction in the cost of goods for the inhaler. In addition to the technical questions, you will no doubt recall that we have been asked to discuss the so-called clinical utility of the product on the basis of currently available data. Because of the rather unusual wording of the request, we saw clarification in the agency and replied with the following, and I quote from the email.”We are basically asking you to clarify where AFREZZA fits in the treatment armamentarium to diabetes," language very similar to that which I use at our update last month. In that regard, we have been following up on additional analysis with explored use of AFREZZA against other therapeutic agents. That’s just the data that was collected in our large long-term usual care study, (inaudible), which was presented in the initial NDA as primarily a safety study. The way the HPA wanted to see was follow carefully for two years in approximately 600 Type 1 patients and 1,500 Type 2. The pre-specified analysis across the groups as a whole showed comparable reductions in HbA1c dosage usual care regiments in both Type 1 and Type 2 patients, and meet the criteria for non-inferiority. In addition, the detailed sub analysis we prepared looking at the various subgroups of therapies comprising usual care will help us in describing clinical utility. In addition, we have recently completed Study 117, and the topline results are now available. The full report will be completed into our response to the agency. This is a four-month study in Type 1 patients, comparing mealtime AFREZZA in combination with a long-acting insulin analog versus a rapid-acting analog, again combined with a long-acting analog, widely considered to be the standard of care. The pre-specified primary endpoint of the study is to demonstrate non-inferiority and the change in HbA1c between the two groups. In this study, we aim to ensure that fasting blood glucose was better controlled at baseline before starting treatment and our titration algorithm was more regressive than in previous studies. Based on our knowledge that we are likely to cause hyperglycemia. Although I do have the fullest analysis available, the topline data confirmed that we have met the endpoint of a non-inferior change in HbA1c and that this result is comfortably within the statistical competence interval. We will update with full information on other endpoints when the full analysis are complete. In summary, we have been busy in preparing a response package that we believe will adequately address the questions raised by the agency and give us the opportunity to have our second-generation device reviewed expeditiously. seekingalpha.com/article/202049-mannkind-corporation-q1-2010-earnings-call-transcript?find=clinical%20utility&all=false
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Post by vdhingra on Jan 31, 2014 14:58:04 GMT -5
Thanks brentie.
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