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Re: ThomasS post# 107910

Tuesday, 11/02/2010 7:38:31 PM

Tuesday, November 02, 2010 7:38:31 PM

Post# of 257257

"We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets teh FDA's criteria to demonstrate chemical sameness..."

In this case, "we" means Teva. Teva confirmed, not the FDA.

Although I wouldn't agree with the interpretation, I could see someone pointing to the "we confirmed" and saying that infers that Teva confirmed with the FDA that the FDA believes their generic Lovenox met the sameness requirements. I.e., I usually think of the word confirming as meaning that two parties agreed on something. But, if that were true in this particular instance, I do think Teva likely would have said they "confirmed with the FDA" and not just "confirmed" by itself to avoid confusion. All told, I think Teva likely misused the word "confirmed" in this context. IMHO, I think "reiterated" may have been what they meant.

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