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To All regarding a Lawsuit:
I think a Law Firm should start a Suit on behalf of the Investors against the FDA for Breach of Contract...
This would start the process moving and put pressure on the FDA while in negotiations with Amarin.
This leave the Company out of any "Gun to the Head of the FDA" by Amarin while they continue to work out an agreement.
I am sure the FDA is not going to like knowing they have a Court issue looming while having a change to openly resolve the obvious differences!
Labner: Did you send this? Hopefully so!
Labner: Nice find! I emailed the links to Speed...
This particular Attorney should receive copies of everything being sent out to Congress, FDA, AdCom, Amarin... to keep him up to speed on our concerns as investors...
Just costs a stamp and/or a phone call.
Hopefully the Team keeps this option at hand!
Hopefully we never have to call him!
Thanks for the follow up!
John
http://www.emord.com/how-the-fda-went-bad.pdf
http://www.emord.com/Jonathan-Emord.html
GREAT ARTICLE on VASCEPA from the PAST:
http://seekingalpha.com/instablog/1122334-iggy-igette/1807081-amarins-fish-oil-looking-beyond-triglycerides
This is what I believe the smarter Technical/Scientific people on this board are saying and is our path to stay on!
JohnKing29
VascepaMiracleDrug: Joe Bruno (Amarin's PR guy) told me they were considering everything when I asked if this was a consideration...
This "quiet" position the Company takes is what irritates everyone.
I am caught between them being smart and working up the ladder little by little at this point or bowing down to the FDA and walking away with their tail between their legs.
NOW: We have no experience with this team caving to the FDA so we are all on the fence as to what will or will not happen!
Chabojilo: This has been my point since AdCom...
Amarin needs to negotiate an OK in the short term for FDA approval to Treat this particular class. Everything else we are all shooting for (complete approval for Anchor as submitted) should continue!
We then at least give Doctors the OK to medicate with our drug!
I called Amarin one evening last week and tried in their "Search Extension by Name" starting with Joe Z's name (Executive last only)from top to bottom and the only extension that was valid by last name on the Executive list was/is Steve Ketchu's...
I left him an extended message asking why they don't ask in the next two weeks in their meeting with the FDA for that particular approval only at least. Just as you see on their website they clearly state for Marine that Amarin is not proven to Reduce Pancreas Inflammation (#1 reason why you give Trig Reduction medication to people in the very high class) and as well it says that it is not proven to reduce CVE's...
Do the very same for the 100 to 499 class to start making headway!
I told him that if the FDA rejected that request then they will have a whole new argument to add to any future litigation that lends to the theory that the FDA is out to get Amarin...
There is NO WAY the FDA can reject a request to allow/approve Amarin treat the 199 to 499 class!
If they did, as you said, they will have to tell the world that treating this class of people is NOT necessary!
Force their hand is what I am saying.
If they say NO: The fight is ON!
If they say YES: We lose the war yet win the fight (for now!)
John
Labner: Thank you for the positive response! Great to hear! Getting guys like him on board at least to the degree of having him read about the issues is all a plus for everyone!
If in fact the FDA overstepped their bounds and lets say it is not wrong to say "Reducing Trigs Reduces CVE's" as is the feeling of the AHA among other organizations, then the FDA should not be able to fail Anchor based on Jesse's position on the entire situation...
This Attorney may have another take on the situation and may be able to get us approved in some form or fashion that none of us would expect...
I am not the guy to take to him in a logical sense meaning I understand the basics yet people like Speed, Billionaire, Jesse... all can take the case to him and let him formulate an opinion at least for nothing...
Thank you for grabbing this!
Any positive signs from it be sure they go to the guys above!
John
JL: Agreed!...
You are convinced they overstepped (and I am not saying that is wrong at all)...
What I am showing is the path to resolving the issue:
Step #1: The upcoming meeting with the FDA.
Step #2: Appeal any negative decision using the FDA's process.
Step #3: File a case in court.
I do not have enough experience to know if they overstepped their bounds and have never said they didn't...
I am ONLY pointing out the path Amarin should take to resolve the issue.
If they skip any path noted above, (I think) we are waiting until 2016 for the Reduce-It results.
It is going to get interesting.
Jesse...
You are correct:
I am "following in no one's footsteps..."
The reason why:
I am following everyone's footsteps.
Big difference in the two sentences.
Chabojilo : We are on the same page...
It does not say that they are Reducing CVE events YET as Joe Bruno told me that was the direct target group.
With that said the FDA does not want high risk people being the target group until we can prove it.
Just getting the approval in the 200 to 500 group would be a big help right now...
JohnKing29
JESSE: You point out a typo in my message:
I meant to write is in "BOLD" below:
Jesse - You pretty much rounded out in Kindergarden language if you will what I am saying.
You promote seriousness yet have a propensity to degrade comments that are not 100% in line with what you are saying or thinking... Keeping conversation(s) above level with others (not bashing) will certainly go a lot farther with everyone than to diminish what is surely a completely valid line of direction (my original message...)
I deal with multi-million dollar contracts and agreements all day long. I am a Contract Manager by trade and have been for the last 28 years.
Amarin still has to follow (exhaust) the terms of Dispute Resolution because Amarin subscribed to (signed) their agreement (agreeing to their terms) just as the FDA is doing right now. If they do not, the FDA can say that Amarin breached their agreement.
At this point "Dispute Resolution" appears to be a Formality in that (in my opinion) there will not be an agreement with the FDA that they (the FDA) did anything of the sort (breaking the agreement and/or contract...)
Either way it can end up in court.
It would be nice to have an opinion from a Lawyer dealing in Contract Law at this point which is why I suggested someone (who can speak about the issues at hand like you, Speed, or Billionaire) call the Lawyer noted in the case the FDA lost in my previous message...
(Health freedom attorney Jonathan Emord)...
http://ducknetweb.blogspot.com/2010/06/fda-loses-in-court-with-violating-first.html
Amarin Stuart Sedlack (Left Amarin in October 2013)...
Interesting reading: His complete compensation package (original offer letter):
http://www.sec.gov/Archives/edgar/data/897448/000119312511300743/d231574dex101.htm
Looks like his specialty was creating the product production network so (if this is correct) losing him at this point is not a big deal...
JESSE (and all other leaders on this Board):
Thank you all for everything you are doing!
I am not an Attorney yet did very well in my Contract Law classes. I deal with agreements and contracts every day.
I am a Long Investor with 17,000 shares.
In "Contract" Law (whether it is an Implied or Written agreement) anyone bringing suit anywhere has to (should) exhaust the requirements of the Contract in Dispute Resolution. I add "should" because a Judge will ask both parties before accepting the case whether they followed the terms of the agreement (I will call it an agreement in this writing because no one has proven at this point that it is a Legal Contract.)
Once all forms of dispute have been exhausted without a successful resolution, either party is free to do what they want IE: File a Law Suit for example against the other.
What has to be proven as it appears one of the major paths that is being discussed on this board is: Did the FDA overstep its bounds in deciding against Amarin whether Intentionally, Unintentionally, or Maliciously.
Where I think the argument will be is:
Did Amarin re-define the terms "Scientific Evidence" and "Efficacy" as they are defined in the Agreement.
Both of these terms have been challenged in the past and can be challenged in the future.
They are winable if Amarin can prove that Amarin could reach a different Endpoint regarding trigs reducing Heart Attacks.
What I think Jesse is saying is Trigs will NOT be what reduces CVE's in Reduce-It YET the reduction of Inflammation - a byproduct of the Anchor submission.
NOTE: There is no clarity in my mind as to whether Anchor's Endpoint is saying: "Trig reduction reduces CVE's" or "Vacepa as a whole drug will prove to reduce CVE's"...
If Anchor is directly geared to: "Reducing Trigs will reduce CVE's" then game over... We cannot win that argument with the FDA nor can we win that with a Judge if other drugs already capable of reducing Trigs do not show to reduction CVE's...
We will NOT get it back on track with the FDA under those stipulations.
Now if we change paths and change the goal by saying: Vascepa will reduce Inflammation and prove to reduce CVE's, we will have to apply for a NDA wil creating new tests with the same Endpoint: "Vascepa will reduce CVE's via Inflammation reduction."
My problem: I am reading two messages that get clouded in my head every day I read this board:
1. Do we keep with Vascepa and Trig Reduction as the that path that will prove to reduce CVE's?
2. Do we argue that Amarin has a product and the product as a whole will reduce CVE's (yet the little secret is it is not in the Trig reduction yet in Inflammation reduction!)
NOTE: Jesse has already said Trig Reduction is not important in the big picture...
NOTE: I agree with him.
NOTE: If we are saying that how can we win with the FDA or a Judge if Trig Reduction is the main point of Reducing CVE's in Anchor?
NOW on the other hand:
If the Drug as a whole is what reduces CVE's and is described as such in Anchor, then we have a completely different game... This is the game I THINK Jesse is saying we need to play.
If we exhaust and fail ALL Resolution paths in the Agreement, then we go to Court and argue that the FDA has mis-used the terms: "Scientific Evidence" and "Efficy"...
If in our favor: The judge will agree and instruct the FDA to re-instate Anchor.
This will then re-write the Agreement language that defines the two terms.
In closing: It is possible to take either path and win. I am hoping Anchor states somewhere that the Drug as a whole is what will Reduce CVE's...
The FDA is ONLY focused on Trig Reduction and that is where Jesse is saying they made a mistake in my opinion.
I will Bump this message a few times later and during the week knowing not everyone reads on weekends...
JohnKing29
Examples of what I note above:
SPA Agreement Resolution:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
Pulled Excerpt from above:
Quote:
• A clinical protocol assessment will no longer be considered binding if the director of
the review division determines that a substantial scientific issue essential to
determining the safety or efficacy of the drug has been identified after the testing has
begun (section 505(b)(4)(C) of the Act). If the director of the review division makes
such a determination, (1) the determination should be documented in writing for the
administrative record and should be provided to the sponsor, and (2) the sponsor
should be given an opportunity for a meeting at which the review division director
will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This
meeting will be a Type A meeting under the PDUFA goals for meeting
management.10
C. Personnel Changes
Changes in personnel on both the Agency's review team and the sponsor's development
team are common during drug development. Personal preferences of new individuals on
either team should not affect any documented special protocol assessment.
VII. DISPUTE RESOLUTION
A sponsor should first try to resolve disagreements with FDA action under the special protocol
assessment program with the review or applications division. Any dispute regarding study
design should be resolved before starting the trial. If the sponsor is not satisfied with the
response provided by FDA, the sponsor can decide to pursue the Agency's procedures for formal
dispute resolution as described in regulations (21 CFR 10.75, 312.48, and 314.103) and the
guidance for industry, Formal Dispute Resolution: Appeals Above the Division Level (March
2000, 65 FR 12019). However, if an advisory committee evaluates a protocol as part of special
protocol assessment, further review by the advisory committee need not be obtained as part of
dispute resolution.
Redefining Substantial Evidence in the FDA:
http://www.fdli.org/resources/resources-order-box-detail-view/will-fda-relinquish-the-gold-standard-for-new-drug-approval-redefining-substantial-evidence-in-the-fda-modernization-act-of-1997
FDA Overstepping their Bounds - Lost Case:
http://ducknetweb.blogspot.com/2010/06/fda-loses-in-court-with-violating-first.html
Pulled Excerpt with clarify towards our issue with the FDA:
In our case:
Substitute the Word "Selenium" with "Pure EPA"
Substitute the Word "Cancer" with "Hight Risk CVE Patients"
Quote:
FDA Loses in Court With Violating First Amendment – Alliance for Natural Health Vs Kathleen Sebelius – Selenium Supplements
The court case stated the FDA violated the first amendment of freedom of speech when censoring truthful scientifically backed claims about how selenium can help reduce the risk of cancer. We see a lot of advertising where the train runs away with some products and their advertising where there is no scientific backed information and that is a different story. Many doctors today recommend many different natural supplements in their practices too. image
This case focused on one supplement only – selenium. In humans, selenium is a trace element nutrient found naturally on earth and trace elements in our bodies. No word yet if the case will be appealed. BD
In this court case, ALLIANCE FOR NATURAL HEALTH, et al. vs. KATHLEEN SEBELIUS, et al., the judge ruled that the FDA violated the First Amendment rights of the plaintiffs by restricting their free speech about the anti-cancer benefits of their selenium supplements.
As explained by health freedom attorney Jonathan Emord who argued the case before the Court:
"The decision... reaffirms that FDA is subject to the strictures of the First Amendment in its evaluation of health claims and it faults FDA for failing to follow that standard, holding its suppression of the selenium-cancer risk reduction claims unconstitutional."
"The Court concludes that the FDA... has not provided any empirical evidence, such as 'studies' or 'anecdotal evidence,' that consumers would be misled by... plaintiffs' claims were they accompanied by qualifications. Moreover, the explanation the FDA offers to demonstrate that plaintiffs' claims are misleading – that the claims leave out pertinent information – is not support for banning the claims entirely..."
My Note:
Someone needs to call this guy to open a dialog: Health freedom attorney Jonathan Emord
BUMP: SHOULD VASCEPA BE APPROVED FOR THE MIXED DYSLIPIDEMIA POPULATION?
author: Elayne Morris
target: US Congress
signatures: 6
Citizens for VASCEPA
October 18, 2013
Dear Concerned Citizen,
The present letter summarizes the specific arguments the FDA Advisory Committee (ADCOM) made against the approval of Vascepa given on October 16th, 2013, and the following monograph directly refutes these arguments with scientific evidence.
(GO TO LINK BELOW TO READ AND SIGN PETITION)
http://www.thepetitionsite.com/542/131/086/should-vascepa-be-approved-for-the-mixed-dyslipidemia-population/
Speed: 17,000 Shares...
FDA gets Sued by a Small Guy and Wins!
Chalk up one for the little guy...
http://ducknetweb.blogspot.com/2010/06/fda-loses-in-court-with-violating-first.html
In our case:
Substitute the Word "Selenium" with "Pure EPA"
Substitute the Word "Cancer" with "Hight Risk CVE Patients"
Someone needs to call this guy: Health freedom attorney Jonathan Emord
FDA - "Scientific Evidence" definition as interpreted by the FDA vs. Amarin...
Could be arguable as this is a unique (one of a kind) situation...
Courts and/or Mediators might decide and/or redefine what "Scientific Evidence" means if this ends up in a dispute...
Different Drugs with Different Properties do not always result with the same Efficacy.
Efficacy Defined:
FDA SPA Dispute Resolution:
Not sure if this is the latest version:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
FDA - "Substantial Evidence": Would be nice to see the complete and current "legal definition" of this term as it applies to the FDA to determine if it was applied correctly in Amarin's case and/or to determine if it is arguable or not...
Probably not if they wrote the definition...
This will be the crux of any Legal Action by Amarin.
Apparently this was a term that never sat well with Applicants...
http://www.fdli.org/resources/resources-order-box-detail-view/will-fda-relinquish-the-gold-standard-for-new-drug-approval-redefining-substantial-evidence-in-the-fda-modernization-act-of-1997
bobjones2731: Can you attach a link to Steve Rosenman's comments?
NICE WORK!
A letter like this (or 100% the same as this) should be sent to every Major Newspaper and Class Action Bio-based Attorney in the US...
Reminds me of this (true) story of mine:
If they do not come to you go to them...
My younger brother was 16, 6'-2" tall, and an 85 mile an hour left handed baseball pitcher in high school.
I was tired of him having played in two leagues since the ago of 8 not getting his due attention.
I created a "Resume" of his success in baseball and sent it out to every Division #1 College in the US (and I mean every one of them...) As well I sent a copy to every Major League Team (National and American.). Also, a family friend and neighbor Gerry Crawford (at the time the Top National League Umpire) was handed (by me) 25 copies to hand out to scouts while working games for an entire season...
The strange results: The Phone rang off the Hook! We were getting calls from several Major League Scouts and as well Division #1 Colleges...
I also took him to a local Phillies tryout which was known to be just a feel-good event for kids... There were (20) Pitchers... They let all of them go except my brother and kept him for 2 or 3 more rotations... A guy walked up to me and asked: "Is that your brother?" while handing me a Business Card. I told him yes... He said: "You are going to need this..."
He was a Business Agent for Major League Players!
Small efforts like your letter may reap big rewards like mine.
Just change the header and send it to all National Newspapers and all Class Action Bio-based Attorney's in the US...
My thoughts too yet it is not happening...
They should have passed this having already started it then put the brakes on all future applications...
That is where Jesse and the likes come in...
Their position is the FDA used their Hall Pass to take the day off...
Jesse: I am a 100% believer in this product and that it will reduce CVE's...
The definition of Efficacy: "The ability to product a desired or intended result"...
If the FDA believes from previous tests that "Reducing Trigs will not Reduce CVE's" (forget that Amarin is a different product - just look at the statement - "Reducing Trigs does not prove to reduce CVE's" - this is their opinion), would you not think this fits the definition of Failed Efficacy?
Look at it from an outsiders perspective...
Let's say the FDA gets 15 more companies that come down the road with a drug that they say will Reduce Trigs and subsequently Reduce CVE's...
How many of those companies should the FDA allow walk down the road again and again and again and spend millions and millions of others dollars to come to the same conclusion?
Here is what I think should have happened: Because Amarin was already in the pipeline when they discovered the others' failures, they should have allowed Amarin thru yet stopped all future applications!
THIS IS WHAT I BELIEVE (ABOVE) IS YOUR FIGHT or BONE OF CONTENTION... Whether it holds water with the FDA or any Legal Eagle is another thing... Truly I hope as you do that it does!
The crazy thought right now: (Technically) - The FDA should not allow ANY future applications noted as a Trig Reduction Product with the Intent of Reducing CVE's. They in effect should ALL be rejected like our was.
Upside: If a Drug is allowed to Reduce Trigs in the 199 to 499 Category for the sake of Modern Health we have that product!
Because the FDA's pattern was to approve an application like Anchor.
Amarin is a company seeking to Reduce CVE's...
Based on previous if not all patterns, they approve almost all Safe and Effective drugs like Vascepa.
Also in talking to their PR guy, his comment to a similar question about doing the same starting now was: "Tests must have an endpoint and they cost a lot of money."
They have a product that begs to be taken in different directions yet right now they are focused on solving this hurdle.
JESSE: Did you watch the AdCom either live or in replay?
I am listening to their presentation now and not being anything near Clinically inclined can only assume that their presentation covered everything a logical reviewing team would need to prove that Vascepa is a valuable product.
If so, what was your take on the Amarin Team's presentation?
Did you feel they hit it out of the park or could have done better?
Do you feel they missed any positive aspects of Vascepa?
Do you feel the (2) people that approved it saw thru the FDA's BS?
Another question: Do you feel the Non-Trig benefits of Vascepa are worth anything to the Clinical world from which Amarin can benefit?
Thanks for your help!
JohnKing29
Kind of like GSK's Lovaza?
The FDA allowed anything the Company wanted to bring to the table. I am sure the FDA knew what the Company would use. If not, the FDA came well prepared to explain why none of the tests proved a reduction in CVE's.
The FDA shot down all of them (and as much as I hate to say if you watch the Video they have good reason to...)
All of the Days events are on Youtube.
I watched the part last night that had the FDA shoot down all studies. It is at the 20 minute mark of the 2nd session I believe.
I think there are a couple sets of Youtube videos which may have them out of order...
Grab some popcorn and watch.
I actually opened them and listened while I worked on my computer. The video portion is mostly a still frame where you see an arm grab a drink or someone from the Company walk to the podium.
I am with you 100%...
It is a wish and hope that they would OK it...
I just do not see how or why they would or could say no.
There has always been an unwritten rule that anything safe and efficient that improves the Lipid Panel is an OK drug to market.
That is what we have in many ways more than Trig Lowering.
If not, we move on with the Marine indication and/or hope for a Partner.
I am OK with that as well...
...and to get the FDA to admit that Lowering Trigs is not good is not going to happen...
See where I am going with this...
Force them to do that... It is not going to happen.
Getting them to OK the Trig Reduction in the 199 to 499 class is our only option right now to make money with this...
All other options out there include: Congressman, Lawyers, Petitions... (Really?)
What other choices do we have with the Drug right now and/or in the foreseeable future?
None except to hold and market the Marine approval and hope to stay afloat.
I am OK with that - I can hold out for another 10 years if necessary...
The same evidence that got the Marine application approved...
Greymatter1 - NOT TRUE - Go look at the Marine Application.
They applied for and were approved for Treating people with high Trigs from 500 to 999 without a target group.
Even going as far as saying:
It is not approved to treat people with CVE's...
and
It is not approved to treat people with Inflammation of the Pancreas.
Inflammation of the Pancreas is the only treatable target that I've found with people in that very high trig class...
So knowing I am right: Why did the FDA approve Marine?
Because the FDA knows there is a need to reduce Trigs at all levels...
Anchor successfully reduce Trigs in the 199 to 499 class.
The FDA had no choice but to reject the entire application because the Endpoint implied treating people at risk or with CVE's...
DID ANYONE EVER HEAR THE FDA EVER SAY: TREATING TRIGS IS 100% USELESS?
No...
Yellow_Bluff: I think you and one other Poster on this board gets it!
I think Amarin went for the Home Run and struck out!
Anchor was ONLY to be an extension of Marine which says nothing about CVE other than to say: This Drug is not approved or proven to treat people with Heart Issues...
The drug certainly did not change so why did they point to a target group in the Anchor Application?
For the home run...
Time to settle for a triple!
If they do not ask in the next week or two then option #2 is best:
Partner...
Option #3: Continue with Go It Alone
Option #4: Get out of the market...
You do not get it...
The FDA wants NO REFERENCE to anything to do with CVE's and Trigs...
Do not mention the two together in any way shape or form...
Do not say: Reducing or Treating or Thinking about people with CVE's and Trig Reducing Drugs anywhere nowhere at anytime in any place or in any world...
OK then - what is left: We have a product that safely and efficiently reduces Trigs!
Why is anyone thinking that alone is not good enough???
They never did say anything of the sort.
All they said is Reducing Trig's has not proven to reduce Heart Attacks.
Show us proof and we will give you an OK to market and label your Trig Reducing Drug that way...
BioChica:
My thought is to get the approval for the 199 to 499 class and let the Doctors decide how they want to Prescribe it...
In effect all we get out of it is a cash influx that we do not currently have.
The FDA will not allow anything in the App or on the Label that states anything about treating people with Heart issues...
In their minds it is not proven.
I am an large investor and have accepted their opinion and position and am looking forward to "whats next Joe".
They FDA approved the other Trig Reducing Drugs with Heart Patients in their Endpoint studies and now as Joe Bruno told me from Amarin yesterday: "The FDA has Egg on their Face."
What else are they to do - just keep approving drugs that have not proven themselves to be successful.
The FDA never said we are going to get an approval - we submitted an application only. Everyone on this board keeps going on at how there is this impression that the FDA owes us the approval.
(How they handle and handled it is subject to review yet keep in mind they made the rules...)
On why it took so much time:
The FDA works at a snails pace and they may have had info pointing to the other failures not reducing CVE's before, during, and/or after we received the SPA... We know they take months to do anything. Was there a time frame they owed us? Did they hold off hoping to maybe approve us then found it to not be a safe or good move for the Government? Can we prove the intentionally or maliciously intended to hurt Amarin? They will take the position that they took the time for the intent of gathering enough evidence to approve or reject the Application in a Professional and thought-thru manner.
I highly doubt we would win a case where "the FDA took too long to respond to the data causing harm to Amarin..." Unless there are written time-frames it will not fly. Past precedence of how fast the FDA works will prevail... They take forever!
The approach we need to take is to work with the FDA to find ways to market the drug to make money to increase the Stock Value for our short term selfish reasons and to get us thru Reduce-It.
We have to pick up the pieces of this drug that has many potential Treatments and find ways to sell it to make money.
The only option right now is to get an Approval to Treat the 199 to 499 Class with Nothing on the Label mentioning the treatment of any specific issue and even if necessary do the same that they did for the Marine Class and note:
"This Drug has not been tested or Proven to Reduce CVE's"...
(Question: Why would Amarin put those words in the Marine Application? Sounds like something the FDA would ask them to do. Best part about it: It worked and got us an Approval then... Why not now?)
THEN we let the Doctors prescribe it as they see fit.
I read that Lovaza currently is prescribed quite a bit for the 199 to 499 class.
Would be nice to have the FDA back that up with an OK.
We need right now to try to take the largest bite out of Lovaza and the 199 to 499 class.
That so far is ALL Vascepa has proven it can do - Reduce Trigs!
We have NO other tests with End Points that will allow us to market the drug any other way without additional Applications, Testing, and Specific Endpoints...
As Joe Bruno told me yesterday: "That takes a lot of money!"
We have two successful Endpoint tests that show it is safe and efficient in reducing Trigs.
Accept it, label it, and sell it that way as we work to prove that Reducing Trigs is beneficial (as we all know it is...)
JohnKing29
sts66:
By "rescinding" SPA based on high Trigs don't need to be treated, the FDA has regulated medicine. Note if you have been treated using Fibrates, Niacin, or bla bla.. and have suffered serious side effects from these medicines you are due compensation. On October 29th the FDA has ruled treatment of high Triglycerides 200-500 is not medically indicated.