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Posts | 10817 |
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Alias Born | 07/17/2006 |
Friday, August 09, 2019 3:30:24 AM
Jas I am asking you to cease contact with the FDA...It is clear that you have not helped the situation (not your fault) but you serve as a source of irritation and your messages sound arrogant and demeaning..Right now this is not helping our cause..If you have favorable contacts in the senate or elsewhere: maybe contacting them in a non adversarial manner could help...But please no more contact with FDA...
I do believe the place to fight this battle is in the Federal Courts..Judge E. would be a good one and I believe he is still available for dispute resolution..
FDA looks very childish here...Sending this late hour change...Granting a Priority Review and then replacing with an extended review..leaving the company dangling over the AdCom issue...One that is FDA knows Amarin stakeholders are very nervous about...Why are they punishing us..Why are they using their power to delay the label of a drug which is not only very effective therapeutically in the most important indication in all of medicine, but is also cost effective..Both the AHA and the ADA have endorsed this drug...They represent the doctors who treat these patients..FDA is not licensed to practice medicine and should never over rule professional societies who treat these patients...
Delaying this drug's approval based on three year old temper tantrums is unexceptionable...Amarin needs to to take these ego bloated bureaucrats back to court..
":>) JL
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