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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