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ZBD or others...thoughts
http://charts.stocktwits.net/production/original_13661080.jpg?1369022148
Looking at the past Lovaza launch we see a very predictable growth pattern.
August 2005 8 weeks up, 4 weeks flat, 4 weeks up, 4 weeks flat, 8 weeks way up January 06 to March 06. Then a very consistent growth pattern of 4 weeks down and 8 weeks up. (With some of those 8 weeks being a mix of down, flat with a killer 4 weeks up)
I think we have entered this growth pattern, with a slight variation our first growth spurt covered 12 weeks. We seem to be on our flat 3rd week with most likely a flat 4th May 17 weekly. May 24,31,June 7, 14 should be solid growth.
This pattern could be what JZ was reffering to after 5 visits prescribers tended to pick up scripts. It might be related to sales calling patterns with more frequent 5 visits then moving on to a new provider while working your way through the list of 30,000. 4,000 MD's have prescribed, about 10 % through target list with an unknown number of visits to those 4000. Our current 4 flat are related to new calls and not 5 visits yet.
The large growth spikes out in 2007 may be related to 2 to 3 mo tier 2 effects.
---------------
Summary....
If Vascepa holds this growth pattern, we can expect a flat next week with very agressive summer growth.
12up- 4flat- 4up- 4flat- (8-up, 4-flat)...repeat
Sts
1) replacements or expansion? It's unclear to me.
2) not contract, direct hires with Quintiles hiring/prescreen for Amarin.
3) might just be the natural course of turnover in a launch
Williams
4-24-2013 The Claims for '319 have changed also. Looks like they might have rolled claims from '899. '319 now has no lower limit for Trig treatment. '319 was combo Anchor and '899 was combo Marine. If '319 fly's it's combo for Marine, Anchor, and REDUCE-IT. That's cool.
Williams
'899 claims allowed, 1 or more capsules claim #7, the two are mixed/combo. Many of the claims not allowed are covered in other combo patents.
1. A method of treating a subject having baseline fasting triglycerides of at least 500 mg/dl comprising, administering to the subject an HMG-CoA reductase inhibitor and 4 g per day of a pharmaceutical composition comprising at least 96% by weight ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject by at least 45% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
2. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
3. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
4. The method of claim 1 wherein said period is about 1 to about 12 weeks.
5. The method of claim 1 wherein said period is 12 weeks.
6. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
7. The method of claim 6 wherein the composition is present in one or more capsules.
8. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.
10. The method of claim 1 wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.
Bravo
You've seen how WS treats Amarin on patent days, right? LOL. '889 is the first of the combo claiming indication for combo to tx > 500 trigs. It includes combining with rosuvastatin, atorvastatin or pravastatin.
It's huge and the reason why GSK aquired Reliant, Provaza's hope was to combine Lovaza/Omacor with statin and enter the cholesterol/>200 trig market. In 2007 the FDA denied this Lovaza indication, because Lovaza raised LDL.
Marine, Anchor, REDUCE-IT is just a combo ramp up. AHA wants to increase patient compliance with combo drugs, a combo Vascepa is the most powerful lipid/Trig drug...ever. Add the possibility of hydroxy-atorvastatin NCE and you have a $10 Billion asset.
----899' claims
1. A method of treating a subject having baseline fasting triglycerides of at least 500 mg/dl comprising, administering to the subject an HMG-CoA reductase inhibitor and 4 g per day of a pharmaceutical composition comprising at least 96% by weight ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject by at least 45% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
2. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
3. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
4. The method of claim 1 wherein said period is about 1 to about 12 weeks.
5. The method of claim 1 wherein said period is 12 weeks.
6. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
7. The method of claim 6 wherein the composition is present in one or more capsules.
8. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.
10. The method of claim 1 wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.
'889 could happen any time today, this week, next week I would think would be the latest.
05-15-2013 Document Verification
It's big, but not sure Wall Street will notice. Certainly BP will notice though.
Great chart, as you'll notice it doesn't go out to 2013;). But it does provide the early launch days that Vascepa beats.
Note mo 4 & 5, are the first Lovaza $5 million per month. This equates to 6,750 weekly scripts assuming no stocking fees for Vascepa. Currently Vascepa is at the $5 million per month growth with stocking.
Lovaza's first $10 million month was 10 months out. Vascepa sales with stocking will be well north of $10 million per month come November 2013. As tier 2 effect rolls in the next two months I expect Vascepa will pass the $10 million mark per month.
Williams
Amarin is hiring primary care reps through Quintiles
http://www.simplyhired.com/a/jobs/list/q-amarin+pharma
40% reduction in trigd
29% reduction in LDL
40 % reduction in VLDL
7% increase on your LDL/HDL ratio (good)
Amazing results that should be shared with the medical world, congrats, words getting out.
No I meant 7-26-2012. That was Vascepa's approval date and when NCE will be backdated from. NCE clock is already ticking, it's 5 yrs from the date of approval. As time passes an Anchor approval 12-20-2913 NME is almost equal to NCE for the 7-26-2012 approval of Marine. I should have been more clear.
NCE on 7-26-12, 13, 14, 15, 16, 7-26-17 expiration.
NME for Anchor approval 12-20-13, 14, 15, 12-2016 expiration.
NCE for Anchor approval 12-20-13, 14, 15, 16, 17, 12-20-2018 expiration.
All possible.
Also, if Amarin can perform a small Phase 3 combo the could get 3 yrs NME under a 505 (b) 2 application.
By the end of 2014 Amarin will have 30 ish patents related to Marine, Anchor, Icosapent, capsule for Icosapent, REDUCE-IT, and combos. So any of the above exclusivities provide Amarin's Patent lawyers time to work.
Williams
The date is approaching where NCE granted 7-26-2012 and NME 12-20-2013 are equal at short term asset valuation. At this point overhang is gone.
The "you can't touch this patent" is 8298554, it's OB'd and solid. It also happens to be the reason the USP change the chemical name of Icosapent Ethyl to "Icosapent Ethyl Capsule".
No EPA generic can compete without the product spoiling. No product containing massive amounts of preservatives can achieve the 1000 mg of EPA per cap. No capsule filled with less than 1000 mg can achieve EPA blood levels of 347 mcg/ml to be considered equivalent. No one could get API cheaper than Amarin.
8298554
http://www.google.com/patents/US8298554?dq=8298554&hl=en&sa=X&ei=j3iXUZWTGI-HqwHGxoHwDg&ved=0CDMQ6AEwAA
Anchor approval sinks Lovaza from the reimbursement angle, unless you want to pay out of pocket Lovaza is done 12-20-2013.
ZBD
"Fish oil" studies have some positive effects when applied topically. They of course smelled horrible though, good thing Icosapent Ethyl is odderless.
Williams
New very interesting FDA find. The document was changed 4-2-2013 (bottom of page) and relates to OT Omega 3's, health claims and dose. Very much related to Vascepa/Lovaza and the absolute respect the FDA is giving Icosapent Ethyl. Enjoy:
FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
P04-89
September 8, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Announces Qualified Health Claims for Omega-3 Fatty Acids
The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.
Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.
"Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States," said Dr. Lester M. Crawford, Acting FDA Commissioner. "This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds."
A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, as outlined in FDA's "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements", FDA is announcing a qualified health claim for EPA and DHA omega-3 fatty acids. While this research is not conclusive, the FDA intends to exercise its enforcement discretion with respect to the following qualified health claim:
"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]
In 2000, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega-3 fatty acids and the reduced risk of CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement.
The EPA and DHA omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional food. For additional information about QHC visit: http://www.cfsan.fda.gov/~dms/lab-qhc.html.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108351.htm
Williams
Yes, Final rejection really means cut the BS, give us more money, and some GOOD reasons why we should allow this.
The argument that the Vascepa hydroxy lipitor was completely unexpected. Obviously we assumed that a lipitor Vascepa combo would work good, but the less powerful solo metabolite hydrox lipitor was more powerful...unexpected...and a BFD. We'll win the argument, they need to dance around to stiff'n up the arguments.
Why a decision is likely tomorrow.
New FDA MAPP policy's Manual of Policies & Procedures (CDER)
MAPP 5000.6R1 posted 5-7 and effective 5-2 Office of Pharmaceutical Science Coordinating Committee (OPS CC)
Purpose:
? This document describes the organization, membership, responsibilities, and procedures of the Office of Pharmaceutical Science Coordinating Committee (OPS CC) in the Center for Drug Evaluation and Research (CDER). OPS CC serves as a forum for identifying and discussing scientific, technical, and regulatory issues that may require OPS to develop and implement applicable policy.
MAPP 4512.2 posted 5-13 effective 6-10 Conducting Effective Meetings in CDER: Remote Access Considerations
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
-------
Both new CDER policy relate to meeting and making decisions that are difficult, like Vacsepa's NCE status. It looks to be the wrap up on the over haul of CDER MAPPs.
Well why is this the end? Both policy's relate to being efficiant with the FDA deciding difficult policy procedures and then actually have the time to meet, thus we have the 4512.2 policy going into effect and oraganizing teleconference meetings. It would truly be pathetic for the FDA to submit such policy's without the Vascepa decision being made...as Amarin waits for a decision CDER has met and revised pages of policy.
Tomorrow finally....???
NCE/NME only provides short term valuation and security for Amarin to follow through on business plans, without the decision Amarin and shareholders are on their own.
Williams
Agreed, cognitive dysfunction...gonna have to use that one LOL
MAPP 5000.6R1
MAPP 4512.2
Two new/revised FDA policy nothing directly related to Amarin or NCE, but they both involve improving efficiency of decisions.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
My last emails from the FDA: May 3 rd.
Dear Williams,
As previously stated, no further information is available from FDA at this time regarding exclusivity for Vascepa.
Best regards,
B.C.
Drug Information Specialist | Division of Drug Information
Center for Drug Evaluation and Research | Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed
------------
Prior emails have stated no decision has been made...so I assume yes a decision has been made but we're not telling you;)
Response from an April 25th email:
Dear Williams,
Thank you for writing the Food and Drug Administration. Your inquiry was forwarded to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER) for a direct reply.
The Agency is currently reviewing Amarin Pharma, Inc.'s request that FDA grant 5-year new chemical entity (NCE) exclusivity for Vascepa. No further information is available from FDA at this time regarding exclusivity for Vascepa.
Best regards,
B.C.
Drug Information Specialist | Division of Drug Information
Center for Drug Evaluation and Research | Food and Drug Administration
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed
Someone post to twits cause they've mentioned it.
Williams
Yes, good stuff. Pfizer is definitely watching this patent.
Some Amarin hx: If anyone was curious as to how Amarin got the idea to combine hydroxy-Lipitor with Vascepa, it most likely came from Dr. Doogan, a former Pfizer empolyee. LOL...
"LONDON, April 10 /PRNewswire-FirstCall/ -- Amarin Corporation plc
(NASDAQ: AMRN) ("Amarin" or "Company") today announced the appointment of
Declan Doogan, M.D. to the newly-created position of President, Research & Development.
Most recently, Dr. Doogan was Senior Vice President and Head of
Worldwide Development at Pfizer Global Research & Development. In recent years, he held a number of senior positions in Pfizer in the US and the UK.
Dr. Doogan joined Pfizer in 1982, where he led the Zoloft clinical
development program."
Plus if the FDA didn't grant NCE I would tell them to take their $52 million dollar per yr REDUCE-IT study and shove it up GSK ass. That clears Amarin more cash to develop their business.
Williams
"converting Lovaza customers"
When Vacsepa get's approved for Anchor, Lovaza will lose reimbursement over 2014...
Vascepa assured $1B plus 2014 thanks to Lovaza sales reps.
Thanks for the update. Thiis is the reason GSK bought Reliant, the combo. Pronova oversold and underdeliveried with that pipe dream.
Like the 1:1 share purchase of Amarin stock:) LOL
Another reference:
http://www.lazardcap.com/eventList.aspx?tn=4&ln=1
Merck looking for financing?
Moody's lowers Merck's guaranteed debt to A1 from Aa3; stable outlook
Moody's Investors Service lowered the long-term ratings of Merck by one notch, including the guaranteed senior unsecured rating to A1 from Aa3 and the non-guaranteed senior unsecured rating to A2 from A1. This action concludes a review for downgrade initiated on May 1, 2013. At the same time, Moody's affirmed Merck's Prime-1 commercial paper rating. The rating outlook is stable.
http://beta.theflyonthewall.com/permalinks/entry.php/MRK;JNJid1500266/MRK;JNJ-Merck-sells-interest-in-Johnson--JohnsonMerck-consumer-pharmaceuticals?symbol=MRK
Amarin has a meeting with Lazard Capital tomorrow.
http://www.theflyonthewall.com/permalinks/entry.php/AMRN;SINAid1440907/AMRN;SINA-Stocks-with-call-strike-movement-SINA-AMRN?symbol=AMRN
"Amarin management to meet with Lazard Capital
Meeting to be held in the Mid-Atlantic area on May 16 hosted by Lazard Capital"
Hummmmm:)
More stupid organic chemistry to fill your time with before the FDA rules. It might not happen today, tommorrow or Friday...but it will happen.
http://en.wikipedia.org/wiki/Carboxylic_acid
Williams
Salt ?
One of Icosapent Ethyl's synonyms is Ethyl eicosapentaenoic acid.
acid + base ? salt + water
base = OH-
2 H2O ? H3O+ + OH-
Icosapent Ethyl is a pro drug of EPA also. EPA is Eicosapentaenoic acid.
I know this is confusing but:
"In chemistry, salts are ionic compounds that result from the neutralization reaction of an acid and a base. They are composed of an equal number of cations (positively charged ions) and anions (negative ions) so that the product is electrically neutral (without a net charge). These component ions can be inorganic such as chloride (Cl-), as well as organic such as acetate (C2H3O2-) and monatomic ions such as fluoride (F-), as well as polyatomic ions such as sulfate (SO42-)."
Most think of ionic sodium cholride salts, but salt forms can be organic.
Help?
Williams
Yes, it's a multilevel decison, she's the one that will fill out and sign the form and is the "manger" in charge of the Marine NDA.
Or someone knows it's delayed. The whole event is a trading catylst's and means nothing long term. Short term it could hold up a comarketing deal, financing, and buyout...this is why the FDA has to step up. The volume is low so I don't expect anything was leaked, just run of the mill steel weak shares with robot trading.
Katie Johnson, at the FDA, has one small form to complete and this is over.
Williams
Yoyo
First the chemical name for Vascepa is Icosapent Ethyl, this happened also be the chosen name the USP or U.S. Pharmacopeidial Covention chose. Notice when you read MAPP 5021.1 how many times USP is referenced. The USP changed it's Monograph naming policy and CDER is applying this change to their policy's. So in the eyes of the USP and the FDA Vascepa is Icosapent Ethyl. Yes, it does have an ester linked covalent bond but the naming of Vascepa doesn't include "ester".
The USP's Monograph name for Lovaza is Omega-3-Acid Ethyl Esters Capsules.
http://www.usp.org/usp-nf/official-text/errata-table?mono_num=2609
So not only does the FDA consider Lovaza two separate chemicals with two individual draft guidances, but the USP also considers the two separate with two different mongraph names. This is also one of the reasons why this has been delayed so long. 5021.1 was posted and effective 2-20-2013.
5021.1 excludes esters like Omega 3 acid Ethyl esters, but includes Icosapent Ethyl.
My interpretation of reading the documents I have found.
Icosapent Ethyl has many synonyms which makes this topic confusing, it's not an accident the FDA & USP are chosing their words carefully in all policy's related to Lovaza and Vascepa.
I hope this answers your great question?
Williams
Amen Jess
NCE means jack sh!t with the IP. Yes, I agree Vascepa instigated change.
Williams
Guy,
The evidence you produced is old news and currently outdated. MAPP 5021.1 was effective immediatly when published in March.
I encourage you read the whole policy, but to save you time specifically page 3 "C. CDER Application of Exceptions".
"b. Scientific evidence demonstrates the salt form affects the absorption, distribution, metabolism, and/or excretion (ADME) of the drug in a manner that influences the clinician’s product selection"
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM340273.pdf
The Plasma EPA levels after 4 grams of Lovaza are about 60 mcg/ml (about because they give the range of all 20 subjects dosed). The Plasma levels after 4 grams of Icosapent Ethyl or Vascepa are 347 mcg/ml or 578% higher than the max dose of Lovaza approved by the FDA. I would say that's "exceptional", and would be deserving of an exception. These are facts that can't be argued, they are printed FDA documents. Most new after the approval of Vascepa 2012. Your old documents mean nothing to the decisions to be made regarding Vascepa's NCE status.
This happens to be the whole design of a prodrug, it provides vastly superior delivery of active moiety to the target.
Lovaza's active moiety was ill defined. The FDA has clearly defined it as a mix of ethyl esters (excluded from MAPP 5021.1 policy) extracted from fish.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
Vascepa's active moiety is Icosapent Ethyl, very well defined and described as a prodrug in it's FDA approval documents. It is derived from fish oil.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf
The two have separate draft Guidances for a reason, they are consider two different active moieties...period. Not my opinion but fact at the FDA.
Circular arguments can be made on this all day. I believe I'm correct.
The FDA considers Icosapent Ethyl a prodrug of EPA. The active moiety is Icosapent Ethyl that acts as a type 2 prodrug activated by pancreatic lipase. A 4 gram dose of Icosapent Ethyl achieves 575% greater plasma EPA levels when comparing to a max dose of Lovaza. This is exceptional and falls under the exception in MAPP 5021.1. This is my opinion after reading all these documents, your free to bet against me.
Williams
Many good charts in the Medical review. EPA blood levels, obviously the key to success.
First it's Icosapent Ethyl;). The FDA was not prepared to make the decision. In 9-2012 they approved a therapeutic equivalence for Ethyl Ester of Omega 3, this was after Vascepa approval. Icosapent Ethyl therapeutic equivalence document came out 4-2013. These decisions don't directly have anything to with NCE except differentiate the difference between Lovaza and Vascepa. The two documents clearly list two different chemicals.
Other Prodrug that have been approved have also mistakenly been given NME only for the FDA to go back and correct this mistake. Example, Emend decision.
You are so right, if it quacks like a duck it's probably a cat!?
"An ester linkage", first Ethyl Esters are well Esters no slap anything on to it. LOL
Second an Ethyl was slapped on...covalently. Third, the new salt MAPP excludes Ethyl Esters.
You can't go around slapping esters onto old drugs and create new ones:
? Active moiety - The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester,17 salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.
If the drug is already an ester and it's covalently bonded to an Ethyl, by definition you have created a new chemical. It happens to act like an EPA prodrug, and has totally separate pharmacology when considering EPA blood levels;). NCE--yes, when---only the FDA truely can answer this.
Icosapent Ethyl is a prodrug of EPA, stated in the FDA medical review....I didn't make that up, the FDA did.
LOL, sounds like a probasher trying to create doubt. He should probable read the MAPPs r/t salts, take some organic, then get back to me.
I will keep you informed, next appointment is 5-22, walking out with two scripts...I hope. Both will be out of pocket and off label. Hopefully ignite a fire in the Psychiatry World, there's a few depression studies out...
Parent with an Autistic child will try anything.
No, that's great! When Anchor is approved Lovaza scripts will be history for a multitude of reasons. Lovaza's growth will be Vascepa by the end of 2013.
Thanks I saw that, What path do you think they will take? If Pfizer wins a BO all hurtles go away;).