Janet's going to rue the day that she said the following:
"38. FDA's decisions regarding Amarin's proposed speech described in the June 5 letter were influenced by all of the factors describe above. They reflect a concern that manufacturer communications about unapproved uses are more likely to be helpful to healthcare professionals if they are based on solid science."
Nothing solid about FDA's science with the three trials, however, an avalanche of new evidence that they won't even consider.
This is New Jersey specific. Also, I understand that "A-1932" refers to the "sitting number", which I believe was a few years ago.
You're going to have to provide more detail for me to consider this as credible and important.
Anybody got some numbers on this? I'm surprised that there has not been much movement in the share price, although some might be waiting for the "final word" regarding the two court cases
Seems like it might be a good project for the company's CFO to kick off with the SEC, given that some things are starting to go our way. Can we help him in any way, shape or form?
We didn't know that you liked to do that. Anything else you want to tell us??
Is it now a "requirement" to join the "brotherhood of MBMP"?
They're taking a beak because they're exhausted from "pushing so many "iggy buttons"; bye.
The way that you spell, you must be a very junior "MBMP"; right??
Also, probably a high probability that you did not finish grade 3, if you can't read the letter.
Otherwise, you and the rest of the "rat's #$%$" are getting pretty restless and desperate.
The situation is ludicrous when a company that has spent millions on a research program and securing "good manufacturers" and quality programs for a product to be considered "pharmaceutical", cannot make the same claim as a "back alley" company in China or Utah that has done no studies, and may use contents that are suspect, to say the least, or not of standardized quality or composition!
One more example of how the FDA is discriminating against our company.
Personally, I don't think that the company should accept this and should proceed to trial.
Some qualified distribution of info to healthcare professionals is acceptable (with a bunch of caveats) but the company can't make the same claim as dietary supplements unless Vascepa is reclassified as a dietary supplement. This would negate the pharmaceutical thesis of the drug and place it and the company in with dozens or hundreds of others.
What are you, some kind of "sleeper alias" for Bobo; or did it take you the past 15 months since March of 2014 to obtain your "MBMP"?
Working hard in the past two days to climb the ladder; good for you!
I think that the FDA is not particularly interested or concerned about patents. If there is an opportunity, they will be inclined to accept ADNA filings and review according to safety and efficiency. It then becomes the responsibility of the company to ensure that patents are enforced, if others are to be kept out of the market. Large pharmas could tie up our company for a long time time.
So... Getting back to my original comments, despite Moss' well-argued decision, is this really over? IF the FDA appealed the decision at the last moment (notwithstanding that they might look like fools etc), could the FDA have grounds to still accept the ANDAs? IF they did, we are in uncharted territory as to how this all might play out and there would be "chaos and uncertainty" for months, if not years.
As to another post on this topic, after following this company closely and holding shares (some years more than others) since 2007, I'm just a bit cynical when management says we "plan" or "believe".
Sure, the sales have not been as hoped; however, they are increasing, and at a faster rate than other products in this space. I'll even accept that the company did a lousy job in the early days. What you fail to mention or consider is how the playing field has been tilted against the company in terms of insurance coverage and free speech.
I figured that I would get such a reply from you and your friends.
Other thoughtful comments, please? Anybody who knows the "real" mechanics and procedures of such circumstances?
Decision was provided on May 28.
FDA has 60 days to appeal, which takes us to July 27( the day upon which NME protection expires and ANDAs will be accepted).
If the FDA drags this out and files an appeal at the last second (and considering going that NCE is still not "official" until granted) is an opportunity created for all of the ANDAs to "squeeze through the cracked in the closing door"?
Are we headed to judicial quagmire with the "horses already out of the barn" if FDA appeals?
Is this possibly why the increase in share price was so muted in the days after the decision?