Biotech Values

[mouton29]

<<• Soon: FDA’s written response to legal complaint by Amphastar. This may provide insights as to how far removed from approval the Lovenox ANDAs from Teva and Amphastar are. >>

One of the litigators on this board can chime in, but I'm not sure whether there will be anything useful. It seems the answer was filed on February 2 but under seal, and unless Amphastar prefers otherwise, what we will see ("promptly") will be a redacted version of the answer. See the following from an unopposed motion filed by government. Maybe even the redacted memo will be useful.

Pursuant to this Court’s Minute Order of December 23, 2010, the government is
obliged to file its response to the Amended Complaint no later than February 2, 2011. In order to
comply both with that obligation and with its obligation to protect the confidentiality of
information submitted to FDA by Amphastar, it is necessary for the government to file its
memorandum and the Administrative Record under seal on February 2, 2011. Simultaneously
with the filings under seal, the government will serve copies of the memorandum and
Administrative Record upon plaintiff. Promptly thereafter, the government will, after
consultation with Amphastar, file on the public record redacted versions of the memorandum and
Administrative Record, or, if Amphastar consents, file the memorandum and Administrative
Record in unredacted form.