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Re: Atom0aks post# 208887

Wednesday, 08/14/2019 5:33:10 PM

Wednesday, August 14, 2019 5:33:10 PM

Post# of 426697
Atom....

"An Advisory Committee meeting may be held for one or more of the following reasons. Note that this is not an exhaustive list.
1. The application is an NME.
2. The clinical trial design used novel clinical or surrogate endpoints.
3. There are significant issues regarding safety and/or effectiveness of the drug or biologic.
4. The application raises significant public health questions regarding the role of the drug or biologic in the treatment or prevention of a disease."

1) an NME.....no

2) novel clinical or surogate endpoints...Not that I am aware of...

3) Significant issues regarding safety and/or effectiveness of the drug... NO

4) The application raises significant public health question regarding the role of the drug in the treatment or prevention of a disease....

Pray tell me which one of the four reasons you think covers Vascepa...Or are we back to the BS ?

tia ":>) JL

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