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RockRat

10/28/10 11:39 AM

#107403 RE: turtlepower #107402

Right. Momenta busted them by saying on a CC the request for immunogenicity data was sent to all applicants. Then, much later, the FDA disclosed that in its response to Sanofi's CP this year.

Regards, RockRat
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HattieTheWitch

10/28/10 11:48 AM

#107404 RE: turtlepower #107402

If I understand the facts correctly, Teva received a similar request for data but did not publicly disclose the request. Is that correct?


I have to laugh. TEVA's modus operandi reminds me of a Star Trek episode where the aliens say "We are smart!" and "We are strong!"

You don't have to withhold relevant information and couple it with misleading answers/statements when you're smart and strong!