Post by trenddiver on May 22, 2014 14:52:31 GMT -5
1. Things are proceeding normally and expeditiously with the FDA. They are working closely together towards approval. Hakan said there will be no more CRL letters.
2. They dont expect any problems with the FDA inspections of the Danbury facility which they are readying for production within 6 months of approval.
3. Insulin on hand is in good condition and being monitored. Apparently the FDA will have some say about how much of the insulin can be used. I might be wrong about this but they may be going forward with a newer form of insulin.
4. There are many other applications of the Technosphere platform that are being considered and explored by the company and potential partners. One application that Al mentioned was pain medicine.
5. Potential partners are not involved in any of the FDA discussions.
6. There are no discussions regarding the purchase of Mannkind, but the company certainly would look at offers if such were presented and evaluate them based on patients and shareholders.
7. There was virtually no discussion about Afrezza partnership at the meeting.
8. Deerfield has been very helpful and their interests are very much aligned with the company. e.g. Deerfield does not do real well unless Mannkind is successful.
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2. They dont expect any problems with the FDA inspections of the Danbury facility which they are readying for production within 6 months of approval.
3. Insulin on hand is in good condition and being monitored. Apparently the FDA will have some say about how much of the insulin can be used. I might be wrong about this but they may be going forward with a newer form of insulin.
4. There are many other applications of the Technosphere platform that are being considered and explored by the company and potential partners. One application that Al mentioned was pain medicine.
5. Potential partners are not involved in any of the FDA discussions.
6. There are no discussions regarding the purchase of Mannkind, but the company certainly would look at offers if such were presented and evaluate them based on patients and shareholders.
7. There was virtually no discussion about Afrezza partnership at the meeting.
8. Deerfield has been very helpful and their interests are very much aligned with the company. e.g. Deerfield does not do real well unless Mannkind is successful.
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