Replies to post #215249 on Amarin Corp Plc (AMRN)

[ggwpq]

Mellow, if a DDI were to be required, its results would be considered an amendment to the R-I sNDA, hence warrant another 3-month delay based on the guidelines. FDA would most likely not approve R-I sNDA by 12/28/19 as clinicians could still prescribe Vascepa to patients who need it before official expanded label approval.

[rafunrafun]

M - I agree with pretty much everything you wrote except one part:

But maybe MRC’s CP was the straw that broke the camel’s back. Who knows! But the AGENDA sure matches the concerns MRC’s CP detailed: efficacy.

You guys give Giardino too much credit. You know who else thought that there would be an ADCOM?

Thero.

He has been saying that all along until July 31. He kept saying that Amarin expect one because of the size of the population on label and we have seen nothing from the FDA to contradict that reasoning.

Writing an 80 page dossier in gibberish should not impress anyone (not accusing you of being impressed). I find him to be more on a "crazy" spectrum than on an "impressive" spectrum.

Whoever thinks that Stevie is relevant, just read any of his posts under PYRRHONIAN. They were gibberish then and are gibberish now (Twitter / MRC / CP). Just think what he devoted hundreds of posts to: why RI will fail. Surely if he thought there is an issue with placebo (MO), he would have argued (under PYRRHONIAN) that RI will be positive but because of the placebo.

Here is an example: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=124828722

Again, same then as is now, writes a lot of nonsensical gibberish.

If there was even a tiniest possibility of FDA rejection, all these 3-4 letter organizations would not have put their reputations on the line and recommended SOC. Their reputations is the most important thing to them.