AI
Tuesday, August 16, 2011 5:57:22 PM
OT somewhat
"The FDA often extends an action date by three months."
Back in early March there was a general impression that MNTA was going to conduct a mCopaxone bio-equivelence trial small in number (<30) that may supplement their mC ANDA.
That being the case, would MNTA also expect the FDA to extend an action date by three months as well for mC? My thinking is if the study was completed, written up and presented to the FDA by the end of June, perhaps we "could" hope to here something from MNTA/FDA by the end of September. That would be month 38 that the FDA had the mC ANDA in their hands. Comments?
TIA
"The FDA often extends an action date by three months."
Back in early March there was a general impression that MNTA was going to conduct a mCopaxone bio-equivelence trial small in number (<30) that may supplement their mC ANDA.
That being the case, would MNTA also expect the FDA to extend an action date by three months as well for mC? My thinking is if the study was completed, written up and presented to the FDA by the end of June, perhaps we "could" hope to here something from MNTA/FDA by the end of September. That would be month 38 that the FDA had the mC ANDA in their hands. Comments?
TIA
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