Replies to post #208887 on Amarin Corp Plc (AMRN)

[dmlcento]

Raf, this is obviously MRC with a new moniker. As a moderator, can you report him to the powers that be?

[IgnoranceIsBliss]

No those are just guidelines. There have been many recent AdComs where the announcement went out as much as three months before the AdCom...

Here's an example:

https://www.federalregister.gov/documents/2019/06/24/2019-13354/allergenic-products-advisory-committee-notice-of-meeting

They posted formal notice on June 24 of a Sept 13 meeting (almost 3 months).

They told the company on May 16.

http://ir.aimmune.com/news-releases/news-release-details/aimmune-announces-us-fda-advisory-committee-meeting-date-ar101

Obviously Aimmune either wasn't told to hold off releasing the info, or they ignored the FDA like AMRN did.

[veteranseabee]

Atom,

You can believe those as facts ALL that you want to BUT, it is very obvious that the FDA has NOT followed the PDUFA guidelines to this point. If they had, the adcom would have been announced at Mid-cycle review and it was not. In fact I believe, by timeline, that it was announced after the Late Cycle review. See pages 10-14 in the PDUFA guidelines.

It doesn't matter at this point if that DB is cutting and pasting PDUFA guidelines on twitter or not. The FACT is the FDA has not followed their own guidelines.

[jessellivermore]

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