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sts66: When scripts are filled by a PBM it is realized as a 3 month
script. From what I recall IMS has an adjustment for that, obviously
it affects all Co's , not just AMRN. It's all about revenue recognition.
sts66: What you describe is partially correct. It counts as one
script, but generates revenue that will not be consistent with
IMS data. This happens frequently with PBM'S, and is adjusted for.
Good point. The positive side is that quarterly earnings would
beat consensus consistently, that is until the Sell Side figured it out.
linhdtu: This board is getting caught up with the small stuff, none
of which is going to drive shareholder value. What's done is done.
Going forward the good news is that Vascepa is tracking along at a
similar % week over week increase as Brilinta, Xarelto, Eloquis and
all the newly launched Obesity Drugs. Why don't folks here latch on
to the affirmative, eliminate the negative, and don't mess with Mr Inbetween. Just this week Express Scripts and CVS Caremark gave us
Tier 2 status and more will come. We have an excellent chance to hit consensus $56M FOR THE YEAR. Discussing anti inflammatory effects of
Vascepa is years away. JZ's stock sale was a smart executive move for him. Let's try to insert a positive note to our posts.
It usually represents a cross at the close, and on occasion,
stock put up for buy/sale at close.
Chab: You are spot on ! That said they specifically refer to Lowering elevated Trg's and LDL. They can't claim other metrics
not evaluated in Marine or Anchor.
BIO With all due respect: Since anti inflammatory aspect wasn't
one of the end points in either Marine or Anchor trials, it can't
be claimed in marketing the drug, or be on the label. It's academic at this point.
Ziploc: The reality is that they launched on 1-28-13 and
they only have 2/3 of a Q numbers. April numbers could set
a more positive outlook for the trend going forward. We need
all the help we can get.
When I segued to Industry and Wall St I stopped teaching and
am now Emeritus Professor.
JL: Please read my post yesterday on the NCE. It is completely
factual, and I'd love your comments. I am mystified why I am
the only poster to bring it up and there were non comments.
I know these facts to be true. I have been in the Industry for
the last 18 years, and I speak with hands on experience.
Jesse: With all do respect, Fund Managers have on average 30-35 names in their portfolio.(long/short) The Hedge Funds have really good analysts. The Buy Side are IMO superior to the Sell Side Analysts. They always have dedicated Biotech Managers and have only one God to serve. Their P&L They have no conflict as do the sell side attempting to get the BO and and potential M&A business. AKA Investment Banking. Bottom line they are concerned about Scripts, potential dilutive financing, and the small number of Reps. Selling them short is a big mistake. They are infinitely superior in their knowledge of their Portfolio Co's.
There is an FDA loop hole called " Presumption of Favorability " under which all the various Insulin Drugs, all The Low Molecular
heparin drugs, and various Amino Acids have received NCE's It was
recently used on a Novo Nordisk new version of Insulin. It's a bit harsh to refer to it as a loop hole, but I can't think of another term.
'PRESUMPTION OF FAVOURABILITY" IS HOW ALL LOW MOLECULAR WEIGHT HEPARIN'S, INSULIN'S, AND SOME AMINOACIDS GAINED NCE. I SUSPECT
THIS WILL PROBABLY HOLD TRUE FOR VASCEPA. THAT SAID IT USUALLY COMES WITH A DRUG APPROVAL. ANCHOR INDICATION.
JESSE: THANKS FOR YOUR GRACIOUS RESPONSE. I SHOULD HAVE SHED
MORE CLARITY ON MY NCE THESIS. I BELIEVE THE CO WILL RECEIVE
IT FOR THE ANCHOR INDICATION. I WOULD LOVE TO SHARE MY RATIONAL
WITH YOU REGARDING THE ISSUE THIS BRINGS TO BARE. ALBEIT PRIVATELY.
JL: I AM CONCERNED ABOUT THE PRICE ACTION. WITHOUT THE NCE
THE MARINE INDICATION IS VULNERABLE TO GENERICS, IF AN
NCE IS OBTAINED, THE LIKELIHOOD IS THAT IT WILL BE FOR THE
ANCHOR INDICATION. COMMENTS APPRECIATED. THAT SAID, THE PRICE
ACTION HASN'T MAD SENSE SINCE APPROVAL. WHEN GOOD NEWS TRADES
LIKE BAD NEWS, IT'S WORRISOME.
It's about purity, not mg strength. I'd rather run a clinical
trial using % of purity vs mg strength. 4 mg Vascepa is more
efficacious in lowering Trig's than 100 mg Omega III. If
not than why isn't there PH III data showing Biequivalance to
98% Pure EPA,.
Bottom Line:Even though your attitude is confrontational, I shall try to give you an historical over view. When Omacor was launched, there were many Omega III products on the market. Build a better mouse trap and they shall come. When GSK took over Reliant, they changed the name to Lovaza. It has been doing $1.3B year over year.
with multiple Omega III's supplements on the market. When Zocor was launched, it basically overwhelmed Mevacor. Lipitor did the same to Zocor, as did Crestor to Lipitor. Physicians and patients want the most efficacious product available. The P values for Vascepa for the same indication of elevated Trg's over 500 were off the charts compared to Lovaza. Not sure they teach P values in Dental School, but I'm sure you catch my drift.
Re Anti inflammatory effects, I'm referring to Peer Reviewed
articles. That is the crux of FDA's decision making regarding
label expansion. Hopefully you're spot on. I am a believer in AMRN's
elegant Lipid IP.
Thanks for the reference. As a Physician and Professor at a major
West Coast Medical School, I never rely or give full credence to
Diet/Supplement publications, as they don't perform Gold Standard
methodology. At best they derive their conclusions more on hypothetical's than rigid scientific research.
We really don't have a clue re revenues. If you do the math
their burn rate is worrisome. They can't wait 7 months before
launching for the Mixed Lipidemia indication as we did for The
Marine approval. Sans partner there will have to be a dilutive
financing. Hopefully JZ will be revealing on the earnings call.
Kay: What are your thoughts on a possible dilutive financing
by year end ? They will certainly need money to beef up their
sales force for the Mixed Dyslipidemia launch.
Technically I disagree. The stock has put in a double bottom,
roughly around 6.77-6.81. That said, the immediate future will
be determined by JZ's comments on the earnings call. What can
he say that would inject a note of optimism to AMRN's future ?
Lovaza scripts were up 7% and Vascepa 1.2%. Not encouraging,
unless the silver lining is that Dr's are still supporting the
lowering of Trig's. If the company can somehow avoid a financing
before the Mixed Dyslipidemia approval, I believe the stock will move back up to the $9 range. These are all my major concerns going forward. I do believe that the stock will be supported at these levels.
Hey my friend ! From your mouth to FDA's ears. I love the IP
in fact, it's really a platform technology that will excite
a BOP and drive share holder value. The time to market is either
your way or a shortened PH III Trial. Either way it's a win/win.
Foxwooden: My point is that GSK's drug is further along in clinical
development than SRPT's. In all likelihood SRPT will have to do a
PH III trial.
IT'S NOT FOR NO REASON. In FDA speak, they are strongly suggesting
a PH III Trial will be necessary. They have multiple Gods to serve,
including sensitivities to strong Patient Advocate Groups. I still
feel the stock is a value proposition at these levels. That said,
there is a strong possibility that GSK's drug will have first mover
advantage.This will in all probability bring down the volatility of
the stock.
Medicare Supplemental Part B, which the majority of Medicare
folks have. has the Drug Benefit.
Not exactly. Most Medicare patients have Drug coverage.
What happened 4-1-13, is that Medicare has listed Vascepa
on formulary.This means that patients will have a Co Pay
and have their Rx's for Vascepa covered.
The Anchor Protocol was an SPA, (Special Protocol Assessment) an agreement between FDA and Amarin, that if endpoints were met, approval will occur 10 mos following the filing of the SNDA 2-26-13. The filing was predicated on the Reducit trial being 40% enrolled.
This is considered as a binding agreement for approval. All the criteria were met, and the endpoints, set by Agency were stunning.
P values around .(006-.0003). I believe this is as much of a done deal as exists in Biotechland.
That's the point> NCE gives 5 yrs from date of approval.
I see it as a win/win
Hey Guys: I'm not sure you're looking at the NCE
as FDA historically has handled issuance or non
issuance. The NCE is almost always given with a New
Drug approval. On occasion the decision comes down
3 mos later.There have been a few rare instances of
sponsoring companies waiting years. My take is that
when the Mixed Dyslipidemia indication is approved
at year end, the NCE should be awarded at that time.
It seems apparent that the Anchor patents are key,
as Lovaza is not listed in OB for this indication.
Therefore, no prior art.
Good post richinjun : That said, Cost cutting protocols are rampant
throughout the Provider Universe. The only way to change this is with compelling data, and that will take time. Our big hope is for
more KOL's to pay attention to the fact that though inflammatory factors are the real culprit, elevated Trig's do cause platelet aggregation and in clumping together, are the straw that breaks the proverbial camels back and are incriminated in an acute MI and Stroke.
Jesse: One of the variables in a complex equation is the actual
demand of Rx's for Omega III . Lovaza sales are declining, and the KOL's in Lipidology, are not completely convinced that Trigs are as an important metric as we had believed. In this age of Hospitalists
and Managed Care, most large institutions have Treatment Protocols
for every indication. It just may be that until the Reducit trial
on outcomes is unblinded, the demand may stay soft. I'd like both your thoughts and any others that may shed more light on this issue.
It could be the reason for no BO partner, low PPS, and the real Bear story among Hedge Funds.