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.
I'll take 300-500 tris, instead of the 200-500. The 200 level is a grey area, but 300+ is a known marker for CV, vascular and organ stress. That would be a 'fair' and supportable label edit.
Especially since there appears to be no basis for the question voted on by this panel. It in no way refernced the SPA objectives and endpoints for the study. How did that happen ?
I don't know or understand the science or the investment process, but I do work for the government and I know shenanigans happen - this Administration is case in point. Agencies HATE dealing with GAO and OIG - and if problems are bad enough - it can impact their own bottom line - funding to run the agency.
Perhaps with the heat turned up - we can finally shake a positive NCE lose and have the PDUFA go in our direction - even if conditional only.
I think you guys are dreaming. The FDA doesn't answer to anyone. They make and break companies all the time. PSDV just got the rug pulled out from under it yesterday. Another biotech that is crashing today. ARIA.... there is one that went from 24 bucks a share to 2.50 or something now. Will they get their money back ??? or decision changed, I doubt it.