Replies to post #200869 on Amarin Corp Plc (AMRN)

[HDGabor]

M-

In our view, it is probably more like >80% chance there will be one now.

Meanwhile the FDA could communicate "No AdCom" it isn't an obligation … they have to communicate the AdCom only.

As you know FDA hold an AdCom based on (i) the application [indication or size of the market or etc.] or (ii) review.

(i) as AdCom wasn't mention in the PR letter or the 74-day letter or YTD (till 7/9 evening) … so we could rule out this reason.

(ii) it is possible till approval but the chance is less tan 1% (please note: MO isn't a review issue … atypical lipid changes known since MARINE data and MO wasn't THE "issue" it was one possibility among others for the atypical changes … FDA mentioned other possible reason in THE ANCHOR BD.)

another catalyst is the potential for an out of the blue extension of the PDUFA date … Solicited amendments [requested by FDA; i.e. blood pressure data from REDUCE-IT?]

Your view is based on your analysis only … is it a potential bias?

btw: I was surprised that despite your deep and long analysis you do not know that the BD is part of the protocol …the chance of no BD data in the submission is 0.0000%

They may also inform Amarin of plans to hold an AC meeting therewith, or wait until the pushed back mid-cycle communication to inform them.

??? The mid-cycle review meeting was on June 28 … it isn't a question, it is a fact.

Most - if not all - of your argument / view will be busted by mid-cycle communication which could be PR'd tommorrow 6AM (or "as the latest" by 7/15 6AM.)

I confident in my view as you are in your … no problem with it … as you wrote we will know soon (within a week).

If something looks like a duck, sound like a duck, you call it a cat and will be proven without any doubt that this is a duck: you were wrong … it is B&W.

Best,
G