Biotech Values

[mouton29]

<<Denial of Peptimmune's petition on generic Copaxone by the FDA>>

They deny the petition of the ground that to grant it would preempt the decision in MNTA's ANDA, and that would be premature "before we have had an opportunity to fully review data and information submitted by an applicant or to provide such applicant with appropriate procedural protections."

This would seem to suggest that approval is not imminent, but I suppose there is no way to predict when they will finish their review.