I already posted this in another thread. Here it is again:
As soon as you figure out the correct first fields to Google Docs, append this:
Indeed, the pendulum may keep swinging. I think most people replying to your thread are misunderstanding your stance. That said, I don't have the balls to do it. I always see the good swing trades in hindsight. I would be rich on what I could have done in the past...
Anyway, be aware that the Big Bang will probably happen sooner or later, you don't want to be caught with your pants down on THAT day.
GR8, several posters in a new thread claim you are SR. In that case, I wish to tell you that I like your articles.
Cordially, Dad (aka Bernanke)
Look, this is the last from me on this topic, and the last time I am replying to you.
This is not a situation where two persons of similar backgrounds have diverging but equally legitimate opinions. It cannot possibly be farther from that.
One of them is a SOMEBODY. He has served on FDA AdCom's. He actually knows what he is talking about. He is part of the industry. People in the industry listen to him. He knows every FDA guidance and procedure (he is working with them daily). The other one is a NOBODY, a scam artist, a puppet. Every time he references a regulatory topic, he misunderstands it. Yes, EVERY TIME. I'll use a wild exaggeration in order to make a point: it's almost like a five-year old trying to dispute an article written by a Nobel-prize winner (yes, I know neither is true, only the relative levels of the persons in question are somewhat similar to such a situation).
Even if 90% of SR's predictions are wrong (he is an expert, not a fortune-teller), it still would not contradict one word of what I wrote about him.
Over and out. You may reply if you wish, in which case I will leave you with the last word. Wishing you well.
Of course he is more balanced - someone educated, informed and actually from within the industry is always more balanced than a clown who is making up his shוt - yet some people mention the two in the same sentence.
The 2008 draft for the Guidance:
The FDA gov site, then:
It contains the three scenarios quoted by Birzinho.
Thank you. Good DD. A few posters misunderstood your motives when you started that other thread (and also misunderstood my reply to your thread). Good for you for getting to the bottom of this question (not letting the noise deter you).
I will try to post the link (Yahoo will not notice if I do it in a certain way).
BTW, interesting handle, enjoy your pastime.
Nothing is guaranteed, ever (other than taxes and death).
AdCom is on. I don't think this is going to change. Obviously, no guarantees, just the way things are looking like right now.
I find the "generally speaking" comment is reasonable.
You posted a link and Yahoo did not delete your post. I want to be able to do that when I grow up! (Are you a Yahoo employee using a superuser account?)
It is very simple (and public knowledge), just like SR says.
Vascepa did not need an advisory panel for the Marine indication, as it was not the first approved drug for that indication. The already approved drug, its safety profile and pharmacology have not changed, meaning no concerns. So what is new? It is the first drug to be approved for this indication (Anchor) and the FDA has a procedure in place for this scenario, that's all.
You are right about the discussions and the "concerns". It's all bullshוt, just like 99% of what you see on the message boards. You need to filter out the noise...
Be aware that "they" did not step up anything through this Facebook profile, as it belongs to someone (an investor maybe?) who is not associated with Amarin:
"Disclaimer: The Vascepa Facebook Page is independent of Amarin Pharmaceuticals Ireland Limited and its affliates and is not owned or operated by them. The information posted on [link to VascepaFDAapproved Facebook page] also does not take the place of consulting with your physician to see if Vascepa is the proper treatment option for you and others with severe (≥ 500 mg/dL) hypertriglyceridemia. Always discuss with your doctor to see if Vascepa is the right drug treatment for you.
Information found on the Vascepa Facebook Page may be incorrect and not up to date and we are not responsible in any way for such misinformation or typos. All opinions discussed on this page are opinions of ours and not of others."
Of course, the information therein is still relevant. It's just not an official Amarin media outlet.