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biomaven0

09/29/10 4:02 PM

#105385 RE: mcbio #105372

What about the "never approved" option?



I'm prepared to believe that now that the FDA has set out a detailed roadmap for approval, Teva, given all its resources will, at some point, be able to satisfy that roadmap.

But my working supposition had been that Teva in its initial application would not have met the standards set out, and a reworking would be necessary. That supposition has now been shaken by Teva's apparent degree of confidence that an approval is near.

Peter