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Re: alternatepatel post# 23808

Sunday, 01/12/2014 8:57:04 PM

Sunday, January 12, 2014 8:57:04 PM

Post# of 426184
EPAdrugIntiative CP had 5 Action requests:
1) Delay PDUFDA date Dec 20th by 180 days for CP to be reviewed. (So far granted)
2) Reinstate Anchor SPA (given a date of January 15th action date)
3) Scientific review of three studies (unknown action)
4) Request for ruling on subgroup analysis (unknown action)
5) Requested review of misconduct (unknown action)

The 15th or #2 is not our final goal, now isn't a time to roll over.

JMO
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