Deleted
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Post by Deleted on Apr 4, 2014 9:26:51 GMT -5
Does our plant need to be inspected?
Has our plant been inspected yet?
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Post by notamnkdmillionaire on Apr 4, 2014 9:34:43 GMT -5
Does our plant need to be inspected? Has our plant been inspected yet? Good question. It is my understanding that the plant has been inspected in the past. Usually the FDA will come soon after a new plant is built and validated by the company. So I can pretty much tell you that the FDA has already inspected in the past. As far as the PDUFA of Afrezza, I am not sure if the FDA has or will want to inspect the plant again. They might have already or might prior to launch. I can also tell you that if there was an issue with the plant, we would have already heard about it by now from the FDA. |
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Post by Deleted on Apr 4, 2014 9:54:24 GMT -5
Are any of you expecting a PDUFA delay?
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Post by notamnkdmillionaire on Apr 4, 2014 10:03:41 GMT -5
Are any of you expecting a PDUFA delay? Let me add that the FDA will routinely inspect a plant. I don't know what the interval is. Every year, two years? Not sure. But going forward, the Danbury plant will continue to get inspected and I can bet you that the company has SOPs in place to make sure they know what to do when that FDA inspector comes in. Usually it will be unannounced. Also be mindful that the plant will also have to be inspected by the EMA in order for MNKD to sell in Europe. So the EMA will have to come in and inspect as well. I personally don't think there will be a delay. I think and hope MNKD has thought out every possible label issue and is working around the clock to make sure all is inplace for that hopeful FDA approval prior to or on the 15th. |
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