Momenta Pharmaceuticals, Inc. (MNTA)

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>> Just how long the anticipated approval of the Momenta drug will be delayed is hard to say. EvercoreISI analyst Umer Raffat and his cohorts analysed 20 years of FDA warning letters related to cGMP manufacturing and found that, on average, it has taken 17 months to get them resolved. The median was 13 months and the shortest was resolved in five.


This is typical analysts' analysis that utilized data not applicable to the situation: he was using BROAD manufacture issues rather than specific manufacture issues as comparison, in this case fill and finish specifically. Based on other companies' guidance on fill and finish issue alone, it takes about 6-8 months to get FDA approval if moving fill and finish to a different vendor.