The only reason those incentive to select execs would be given with specific dates attached prior to end of fiscal year would be to meet demands of partnership agreement. Probably not BO as the move is too in your face for that arrangement.
lawsuits irrelevant anyway, all those things were disclosed in the safeharbors and 10Q--was public disclosure from AMRN if anyone bothered to read.
1. unfortunate things is you have no idea what you are talking about
2. safe harbor covers the company--all these facts were disclosed already
3. insurance covers the company to defend these
you were told very wrong. fda action actually exposes them to more risk since they did it after requiring the company to spend and reach all endpoints in the agreed to trial design. they CAN be sued and WILL BE liable--question is, is it in AMRN's best interest to sue???
Recently 2 SVPs related to commercialization and partnering left - they were technically consultants vs. actual employees from what I understand, although they were full time.
There is (unfortunately) no way for conditional approval. FDA only allows conditional approval in 4 categories, none relevant to AMRN: Pet/animal tests; Pressing public safety concern: Limited time to market; and one other I forgot off hand...
Unfortunately, you are not completely understanding SPA. It only guarantees approval if AMRN finishes and proves R-It. It allows for early application for approval, but doesn't guarantee it. An Adcom panel was conducted for this very reason. If R-It showed proof at the end, Adcom panel or not, it would get approved 100%. That's not the case for early marketing request.
this is 100% false. while the rate of FDA overturning panel vote is lower with no votes than yes votes, it's not 100%. 2 recent high profile examples were the weight loss drugs.
you have no idea how fda works, quietly back channeling with fda is the only option, and it works a whole lot more than you think it does. the adcom webcast was a joke, the vote seemed negative but the doctor's comments were completely all over the place and did not provide fda with a firm yes/no on the question at hand.
He is 100% accurate on that comment, FDA already debated this with their own analysis. The one are he is off a bit seems on the combo statin language topic, I do believe it is attached to Anchor approval.
well, hi opinion obviously gets mad respect from wal street -- look at the volume we are up.