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Re: genisi post# 150425

Thursday, 10/11/2012 12:34:33 PM

Thursday, October 11, 2012 12:34:33 PM

Post# of 257566

Teva believes that it can file [thrice-weekly NDA] on the one year data.

That’s what Teva is telling investors, but it makes a lot of sense, IMO, for the FDA to want to see some safety data from the open-label extension insofar as the dose per administration is double the normal amount.

Moreover, Teva does not exactly have a history of playing straight with its regulatory disclosures to investors; Lovenox is a case in point.

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