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Re: mouton29 post# 117280

Wednesday, 03/30/2011 2:13:58 PM

Wednesday, March 30, 2011 2:13:58 PM

Post# of 257573

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.



I would not say it that way. Clearly FDA was under a time deadline to respond to the petition. Once that time was running out they needed to reply.

So I would argue the even another week and the decision not being final on a generic Copaxone could be the basis for what they did.

There is no advantage to FDA reciting their decision until it is final.

JMHO

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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