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Amarin Corporation plc Message Board

  • imapuddytatt imapuddytatt Oct 18, 2013 10:10 AM Flag

    There are ways to pressure the FDA to changing its decision - takes work - but it can be done - GAO, OIG, FOIA, Congressional

    Now is the time for investors and AMRN apply the pressure....BEFORE the decision on the PDUFA is made and its locked in. Whether its a threat of multiple lawsuits on multiple grounds from both the company AND separately its investors, a huge social media campaign, a public petition drive disclosing the FDA and its employees for either corruption or incompetence. Pushing congressional representatives who sit on the various committees to look into FDA practices citing the loss of millions of dollars of constituents money. (The fact the company is registered in Ireland should be neither here nor there when it impacts their constituents.....and also all the millions in capital gains lost to the US Treasury on the taxes those constituents would have paid on their investment had the company not tanked).

    Another path would be pushing HARD on the Government Accountability Office to audit the ADCOM process and drug approval/clearance processes. That puts pressure on FDA to control their rogue adjudicators/facilitators. The push can be by the individual, through your congressional representative or the House/Senate committees with oversight of the FDA. Also, the Office of the Inspector General can look into allegations of corruption. Filing Freedom of Information Act (FOIA) on the ADCOM process and all its facilitators can help expose trends of favoritism or incompetence of certain employees may help open the FDAs eyes to these issues which would be an embarrassment - especially if it is proven they've known problems have existed all along but have done nothing to address the situation. Filing FOIAs on emails and other relevant documents can expose what transpired in the NCE and ADCOM processes as well as PDUFA. With NCE - why the f%@2 its taken so long. FOIA can be filed by ANY private citizen and is not limited to law firms.

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