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louieblouie

01/03/14 7:43 PM

#23376 RE: nycbiotech #23372

I'm not so sure I agree with this....also being a federal employee.

I have serious doubts as to the extent FDA counsel had any input into the voting language of the ADCOM as well as the decision to rescind. Based on what I've seen in the last 18 months - either their legal section is entirely FUBAR or they had no input into any of the decisions made by a rogue division....and now counsel must review and weigh in to try to fix the problem while still trying to save face.

Moreover, I'm sure now that AMRN has their attorneys involved - the FDA must also ensure their's are as well.

Finally - in my agency - NOTHING from the agency goes to the cabinet secretary/department without counsel and director's office review. Sebelius has been getting hit left and right with letters - (I've sent several as have my family members and more are hitting the mail tomorrow ) and the department has no doubt been referring them to FDA for a draft response which may or may not be signed by Secretary Sebelius (especially those that are congressional).

Therefore - while I do think there is a fair bit of conspiring that has gone on with AMRN - I don't think an attorney trying to sort out a legal matter such as this is one of them.
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zumantu

01/04/14 8:25 AM

#23383 RE: nycbiotech #23372

nycbiotech - well said and I agree with your assessment. JL's letter did get noticed and that is a very good thing - indeed
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jessellivermore

01/04/14 8:51 AM

#23385 RE: nycbiotech #23372

nyc biotech..

Thnxs for the input..

The reality is that although I have had a Linkedin page for some time, I have never really done anything on it. Only recently have I upgraded my profile at the request of some on the EPAinitiative. At the time he contacted me the only info on my profile was that I was an MD practicing in the Boston area.

I did send Varrone and invitation to contact me, but so far he has not responded.

Regards

":>) JL