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Biodel Inc. (BIOD) Message Board

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  • biod_factman biod_factman Oct 21, 2010 11:46 PM Flag

    Chance of approval severely underestimated

    I studied the manufacturing issue in BIOD's case (which did not involve Linjeta anyway) and read the warning letter that AMRI got from the FDA, but I am not too concerned with manufacturing issues with biotechs in general. While they are the cause of drug sponsors getting CRL's, I can not remember any case where it really tripped a drug up in terms of getting to the market or taking very long to correct the issues. And that warning letter from the March inspection might be a blessing in disguise to BIOD b/c it would get that whole plant cleaned up in terms of protocol which will help when the FDA inspects Linjeta at the same facility. Bottomline, not concerned at all on potential manufacturing issues.

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