Replies to post #388934 on Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

Failure in the RESPECT trial cannot be defended. It would be a death knell for AMRN.

Only if the results were close to stat sig and the trial were very underpowered would there be any hope under that scenario.

RESPECT can’t restore AMRNs SP itself, but it can give it hope and a little momentum if it was a success. It can, if it failed, destroy AMRN.

[rosemountbomber]

Interesting bigKahuna because when I read that sentence it did not inspire a lot of confidence either. Hopefully, his words were not chosen too carefully, and that they don't have the final data either.

Agree with TTE's take as well. What bothers me is that it makes no sense to me anyway for RESPECT not to be positive. How could a multiyear multination study readout with RRRs of 25-30% and then not be confirmed in a sicker population?

[ziploc_1]

bigka...QUOTE..."But what I can say is we are very committed to stand behind VASCEPA in every way."

IMO this was a slightly ingenuous way of KM saying that he can't, at this time, say more about Respect(now a late breaker at AHA) or Mitigate(hopefully to be admitted as a late breaker at AHA) until the results are released at the meeting.

[Skipperdog11]

"it could also mean that there will be a negative presentation that they are already aware of"

Amarin Leadership is aware of the bio-markers paper being presented (correct me if I am wrong) so they know the usual suspects are coming out to try and seal the fate. I think with the timing here with several European negotiations in critical stages and the negative domestic uptake of IPE, the Nissen group is looking at this conference as its final fatal blow to R-It. We need good data for survival.

[Laurent Maldague]

I think the full transcript reads better. KM is definitely plugging AHA here and to me at least, doesn't sound like he's trying to avoid talking about it or hedge something.
If KM already knows RESPECT EPA is not good (remember this is not Amarin's trial), I'd imagine wall street knows and would have already sold off.

"And finally, we are still working pretty hard on the scientific evidence supporting our products. So at , we presented new data, and we will be obviously present also at AHA."

"Negotiations are progressing for pricing reimbursement in Spain, France, Italy, Netherlands, and we have new submissions. Achieving international regulatory approval in up to 6 countries before year-end is also progressing. We continue to generate data. We are going to have new data submitted at AHA to ensure that we keep supporting the evidence behind VASCEPA."

"Okay. And then maybe just in our remaining minute or 2 here, there are some interesting recent data at ESC. What kind of data can we expect for AHA?"

Karim Mikhail

"I mean there are submissions that are made at AHA, there are no decisions yet. They are all late-breakers. So up to now, we cannot really communicate. But what I can say is we are very committed to stand behind VASCEPA in every way. Today, this product has probably the most significant type of outcome benefit that you have on the market, including 20% cardiovascular mortality benefit, right?

I mean 2 or 3 weeks ago, there was a lot of noise about the that delivers 33 or something like that. This is a one product that by itself does 20%. So we will continue to focus on that space. We stand very much behind the science.

And let me tell you, it's actually very challenging that your study ended literally 4 or 5 years ago and you're still generating science. We have a slide that has how many subgroups were studied after REDUCE-IT. It's maybe 15 subgroups, all of them coming very positive and very significant. So let's see what we're going to have at AHA. We'll see."

https://seekingalpha.com/article/4540443-amarin-corporation-plc-amrn-h-c-wainwright-global-investment-conference-call-transcript