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Alias Born | 01/12/2013 |
Monday, December 29, 2014 5:21:19 PM
April 2015, Hamburg goes in front of Congress to address 2016 FDA budget request. At this time she needs to explain 2014 significant items and address "solutions" that where put in place. As of today, the FDA has acted MALICIOUSLY (Ignoring numerous policy's, Delaying NCE, Incorrectly assigning Exclusivity, and Rescinding SPA) towards Amarin and stakeholders, an Act from Congress is literally due February 13th answering SPA rescindment and clarifying SPA policy. If CDER hasn't answered EPADI CP and/or addressed Anchor PDUFA by 2016 Budget Request....I'd suggest Hamburg bring her Attorney.
My expectations are set so low, I believe we'll get to witness her being extremely uncomfortable at Spring budget request.
What can "I"do?..... BIO, Amarin and industry will apply the heat to Politicians prior to budget request...we just need to make popcorn and watch;). There's a reason BIO didn't hire Ex. FDA Attorney for the Comissioner after he "retired" January 2014. Former Attorney to the Commissioner "may" have greased the wheels for Abbott to squeak out the remains of Niacin 2011-2013 with numerous Patent Exclusivity codes submitted and accepted...despite failed outcomes. (This is why we have conflict of interest laws) I failed to mention, his former EMPLOYER, was Abbot. Anyone looking to follow up on this can FOIA request Abbot Taylor communications...I doubt your request will be met without a supenia.
BB
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