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I agree with you but wall street didn't think so. Joe Z said NCE is an "A", NME is a "B" and no decision will be a "C".
Should FDA grant Vascepa NCE?
IMHO, yes. Vascepa's active moiety couldn't have been previously approved. Otherwise, how can it serves an unmet medical need via the ANCHOR indication. In other words, if Vascepa can treat an illness/disease that none of the previously approved drugs can, by definition, it should be a New Chemical Entity.
When will FDA grant Vascepa NCE?
NCE/NME status is normally decided upon drug approval by the FDA. ANCHOR is a new indication and as a result Vascepa serves an unmet medical need. I believe it's only fair for FDA to start Vascepa's 5-yr exclusivity clock on ANCHOR approval date.
After 2 months of 4g/day Vascepa, it not only makes me healthier but much more optimistic as well.
Stan, apologize for the delayed reply. Just got back from Chinese banquet style celebration (no more fear of fatty liver after greasy Chinese food because of Vascepa). Currently taking 10mg of generic Zocor, plan to cut it down to 5mg and do another round of blood work in couple months and hope to get rid of it all together. I hope to stay away from Statin if possible. I am taking Diovan for high blood pressure as well. After my excellent blood work results, I truly believe the 53% reduction in CVD events in Jelis trial is legit. As a result, we should all be confident in the success of Reduce-It trial.
Just got my blood work results after 45 days of 4g/day Vascepa while maintaining the same dietary habits. I can't be more happy about the results :
1) trigs drops from 254 to 154 mg/dl
2) LDL drops from 111 to 79
3) HDL drops from 45 to 44 (not good)
4) VLDL drops from 51 to 31
5) hsCRP is .3 (first time testing for it)
6) glucose drops from 113 to 95
7) HDL as % of cholestrol goes up from 22% to 29%.
Other benefits of Vascepa I experience so far include the elimination of occasional abdomen pain due to fatty liver, reduced joint pain and dry eyes.
That's the best $127/month (with the coupon) I spent to improve my health. I bet my PCP is going to take notice of my results and start scripting Vascepa to her other high risk patients. Since my LDL and glucose drop so much with Vascepa, I believe doctors can prescribe Vascepa for patients with slightly elevated LDL and glucose levels and eliminate all those unpleasant side effects associated with Statins, etc.
I am so glad I discover Vascepa. Heading out to celebrate!
I think we should all feel very fortunate to be a shareholder of a company that owns 100% of the worldwide rights to a FDA-approved cardiovascular drug with placebo-like side effects. Our competitors, Lovaza, Niacin, Fibrates, etc., can't claim that. In fact, does anybody know any FDA-approved drug with a milder side effect than Vascepa? Good night and sweet dream.
According to Adumb FartStain's fish oil article, it says the following:
"the researchers did observe a significant interaction between the efficacy of n-3 fatty acids and sex (p=0.04), with women treated with fish oil having statistically significant 18% lower risk of the primary end point when compared with women treated with placebo".
That bodes very well for Reduce-It. Female, on average, probably has a better dietary habit than their male counterpart, hence lower AA compare with male. Even 425mg EPA+junk dietary supplement produces statistically significant 18% lower risk of the primary end point. Image what 4g pure EPA would do.
Yahoo finance has 2014 average sales estimate of $278M for Amarin. That's only 3.5% of Marine population and .35% of Anchor population penetration (assuming $2000 per patient per year). Amarin is beyond undervalued.
Akanz, where you get the info. about it's for sale next week, I can't find any info about the combo pill. Please let me know. TIA.
dew, I am thinking about buying CLF. Is there a liquidity risk here, i.e. any near term debt maturity risk? TIA.
no, I am 48-yr old taking Vascepa for anti-inflammation and good heart health. Good luck and health to you.
wmj,
mine is off-label. Do you have TG>500?
rich,
I pay $127 with coupon for a bottle from a local mom and pop pharmacy. So do shop around. I do find national chain such as cvs, rid aid, etc. charge $10 - $20 more compare with smaller mom and pop shop.
If amarin needs cash down the road it can pull a few levers :
1) sell worldwide rights of Vascepa ex-US, ex-Japan (probably worth the current market cap)
2) license Vascepa to Pfizer, AZN, Merck, Lily, etc for combo (each company pay just $250MM and you get the current market cap)
3) sell the company @ $15/sh if the Vascepa launch do not live up to expectation, ala HGSI.
were you born yesterday> small cap biotech never trade on earnings.
according to amarin's most recent presentation, basic shares outstanding is 150MM, 170MM fully diluted. Don't believe YMB, obviously short seller spreading lies.
Amarin management had indicated in previous conference call that it will only update tier 3 to tier 2 coverage change in subsequent earning calls, and not putting out press releases to announce it.
The new guideline seems to say if previously approved drug "D+E" is an NCE, then new drug "D+E+F" could not be an NCE. It doesn't say much about new drug "D" or new drug "E" which might serve an unmet medical need, e.g., TG between 200 and 500 population. The way I see is if FDA say no on NCE for Vascepa, only Amarin will protest so it's easy for FDA to say no. On the other hand, if FDA say yes on NCE, lots of Amarin's competitors will protest so FDA must take its time and make the NCE determination iron clad. So my vote is YES on NCE.
Without insurance and coupon, you are expected to pay at least $189 for 1 month supply of Vascepa. So I think you are not telling the truth.
How you get such a good deal? Without coupon and insurance, the best deal for a 120-gel bottle is $189.
I think you can save your postage on K&E. They have no sympathy for us no matter how moving and reasonable your letter is.
Did everybody used the enclosed envelope sending to Proxy Services in Farmingdale NY when returning the ballot? Just want to make sure before casting my "NO" vote. Thanks.
Jax :
Thanks for your great effort since the beginning of this journey.
Based on your observation in court, seems like the judge didn't realize that lots of us regular "joe", not just hedge funds, are holding the stock. Judge Gerber might not know the debtor is trying to enrich themselves, creditors and bondholders unfairly at the expense of future retirement and educational funds of regular stockholders. It might be a good idea to update the Chemtura Alliance list and get it to Goffman before he shows up in court next time.
Absolutely not.
I do and I have pledged to higher authority not to sell a single share until the company comes out of BK. GLTA.
What happen to our obligatory morning dip?
Marty, take a look at the market (S&P, DJ and NASQAQ). We are experiencing a market correction currently. You can't expect CEMJQ to do too well under such a nasty condition.
Macatak, ignore stock quote of an OTCBB stock after 4:00pm and before 9:25 am. It's totally meaningless. However, keep your dream big but your hope low. That way you won't be disappointed.
And Jax is out working also helps, LOL!
and GGWPQ-ish!
Sully, name me one rich chart guy that you know.
Don't. I have never met a rich chartist.
CEMJQ is very similar to GGWPQ :
1) Asset > Liability
2) positive cashflow
3) file BK because of liquidity not solvency
4) GGWPQ has an equity committee and we will soon has one too, IMO.
I am holding all my shares long and strong.
Jax and WS, thank you so much for your great effort. Judge Gerber's granting of K&E's request to hire Deloitte for Fresh Start Accounting is actually good news for shareholders. Granting K&E its wish means Judge Gerber will probably do the same for shareholders by approving the formation of an official equity committee. Then K&E can't complain that the Judge is not playing fair.
Who said "Q" stock has no value? Look at GGWPQ, up $1.73
so far today. They have an equity committee and we will have one in the not too distant future, IMHO.
WS :
Thanks for your great effort. I feel very fortunate to have you, madclown and Jax as our fellow shareholders. Go get them next week!
If "fiduciary responsibility requires the company to plan for every possible contingency no matter how remote its actuality may be", why did K&E consistently against the formation of an EC?
Is the survivability of the common stock a very "possible contingency" given the excellent Q3 result and improving world economy?
CEMJQ MM, what's the status of equity committee you propose to form? Do you think we need more man power from this board, e.g. top 10 stock holders from this board (owner of at least 10% share outstanding no doubt) to petition to the judge for its formation?
Let’s analyze the risk/reward here :
1) Common share canceled due to the lack of asset sale and refinancing, probability is about 33.3%, potential loss is $.50/share. ( I assume if the stock drop to$.35, the market is telling us the common stock will be canceled).
2) Common share diluted due to debt for equity swap, probability is about 33.3%, potential gain is multiples of current stock price when the next chemical cycle peak.
3) Common share intact due to significant asset sale, probability is about 33.3%, potential gain is even bigger multiples of current stock price when the next chemical cycle peak.
You can assign your own probability, but I think we have an asymmetrical risk/reward situation here.
Please don't spread lies. WCIMQ's total asset is $1477.96MM with total liabilities of $1992.55MM according to google finance. Learn to read a balance sheet before you post next time.
Do you know the amount of Chemtura's NOL? Does the company stated that in order to preserve the NOL, its common stock has to stay? Thanks in advance for your reply.