academic physician
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This is what I posted on the YMB.
Delay in SPA Decision is Very Positive
Contrary to what many shorts believed, the FDA is taking the decision to reinstate the ANCHOR SPA very seriously. If the decision was already made not to reinstate the ANCHOR SPA as the shorts have contended, this would have been announced today without any further delay. This would have been an easy decision.
However, it now appears that the FDA is ready to reinstate the SPA and negotiating with Amarin regarding the the ANCHOR sNDA approval; and in what form that will take place. Most likely, ANCHOR sNDA will come with some restriction (whether boxed warning or regular warning) cautioning about the lack of cardiac outcome study and possibly conditional approval linked to REDUCE-IT outcome results.
If they were not close to a final compromise, the delay in the FDA decision would most likely have been announced earlier in the week- not at the last moment. To this point, PR stated "based on dialogue with DMEP, Amarin does not expect the delay to be for a significant period of time." Any way, I see the delay as a very positive development.
IMV, the FDA would not have delayed the decision twice if they did not intend to reinstate the ANCHOR SPA and approve the sNDA- it appears that there will be a compromise that would best serve the patients with high TG levels and address FDA concern. I believe the final approval will come with either a warning regarding lack of cardiac outcome data, conditional approval linked to REDUCE-IT data, or limited approval to a sub-population of high TG patients with low HDL. The approval is likely to come sooner than later.
GLTALs.
Speedrunner
This was a compelling post by Akanz asking for help and requesting that everyone write letter to the FDA requesting reinstatement on the ANCHOR SPA and sNDA approval.
"I need your help ...a letter writing campaign
I have a lipid disorder ( hetero familia hypercholestremia ) , my mother had diabetes , my wife treats those on dialysis and those who have kidney disease.
Vascepa has the potential to lower the risk of heart attacks for all the diseases and disorders ( plus more ) mentioned above.
We need easy and affordable access to Vascepa WHILE WE WAIT for the results of the Reduce It Trial.
You can help by writing , faxing , email ( not sure if email will work ) some of those listed below , urging that Amarins SPA be reinstated and the Anchor indication approved for those at risk .
Vascepa is a very safe drug ...theres little to no downside from using it.
Please write / fax / email to at least the following
Dr M Hamburg FDA/OC
Dept of Heath and Human Services
200 Independence Ave SW
Washington DC 20201
Fax 301 847-3531
Email Margaret.Hamburg@fda.hhsDOTgov
Dr Curtis Rosebraugh
Director
10903 New Hampshire Ave
Silver Springs MD 20993-0002
Fax 301 796-9717
Email curtis.rosebraugh@fda.hhsDOTgov and Dr Jean-Marc Guettier ....same address but fax 301-796-9717 email jean-marc.guettier@fda.hhsDOTgov
Now is the time to act ...please do so"
My response:
Akanz,
Thank you for sharing your story. This is exactly why Vascepa should be made available for patients. Doctors and patients should have a choice. Many patients continue to have high TG levels despite being on statins and are at an increased to have heart attacks- Vascepa is clearly the best choice for these patients. It lowers TG and LDL and have much better safety profiles than other TG lowering drugs.
You have always been a very thoughtful person and written helpful messages and added insightful comments- much thanks.
I am glad to be of help and have written letter to reinstate the SPA and approve the sNDA.
I believe that the FDA recognizes that they made an error and will reinstate the SPA on 1/15.
The letters will be very helpful in letting the FDA know that the public cares about this issue.
I also urge and ask everyone to write letter to the FDA requesting the reinstatement of the ANCHOR SPA and sNDA approval- this will be very helpful in getting the ANCHOR indication approved.
Speedrunner.
FDA will be meeting this week to determine the final outcome of the ANCHOR SPA- please make your voices heard now.
Citizen Petition has been accepted and posted for comments.
Contrary to some misinformation being propagated, the citizen petition has been accepted and posted on the FDA website. Go to regulations.gov and search FDA-2013-p-1612. The petition is now open for comments. It is an excellent document- factual and to the point.
Thanks to EPA Drug Initiatives and its members for submitting this crucial document.
Speed
Final share count 11/4/2013
The total share count is 5,114,103.
I want to thank everyone for sharing their share count with me and for your willingness to participate in a unified front for a common goal. I am also thankful to all of you who have shared your compelling stories. Most of us have suffered great losses so far. It certainly has been a nightmarish scenario. However, all is not lost yet. Bottom-line is, vascepa appears to be a great drug and, so far, the data from Marin and Anchor clinical trials have been excellent. There is also compelling reason to believe that Reduce-It outcome study will demonstrate positive clinical outcome.
FDA’s review had major flaws and the rescinding of the SPA based on the 3 poorly designed outcome studies lacks justification. However, this is the situation we find ourselves in. It is clearly an uphill battle to reverse FDA’s position but a battle that we may be able to win. We have to fight this injustice.
There are number of shareholders (with excellent qualifications) that have come together to lead the fight against FDA’s unjustified rescinding of the SPA. There are several initiatives being taken by the group to organize the fight against FDA’s ruling. A web-site has been launched that has compiled many important dinfo related to vascepa including the FDA panel meeting info. Please visit epadruginitiative.com. Additionally, a letter campaign is being initiated to congressional oversight committee that overlooks FDA, direct letter writing campaign to FDA director and leaders, contacting news organizations, and initiatives for media release. We are also in the process of organizing other responses that will maximally pressure FDA to reverse their position. We know the time is short and that we need to take initiative in a timely manner. We are in the process of assessing the best options for maximal impact. Some of the strategies may require action by masses to have the maximal impact. I will keep the board updated in these initiatives and if we require your participation. We have several important initiatives planned for the immediate future which I will update as it happens.
I will also suggest what we might be able to do with the combining of the shares for a united action in the near future.
Please feel free to contact me at speedrunner199atyahoodotcom with any great ideas.
Speedrunner
Update share count 11/2/2013.
8:00 PM mountain time.
The total count reported to me is 4,823,749. The total count is very impressive.
I will continue the share count for 1 more day. Once I have the complete share count, I will then propose how we may affect influence on AMRN and would also welcome suggestions from the MB.
I want to thank everyone for sharing their share counts with me and for joining in to participate in a unified front for a common goal. I am also grateful to those who have shared their compelling stories- it is very touching.
I am aware of number of initiatives that are in motion including a formation of a dedicated website on vascepa (http://epadruginitiative.com)- now up and running- please visit, a letter being submitted FDA oversight sub-committee, contacting major media outlets, letter writing to FDA, major medical organizations and cardiologists. Some of this activities will be completed within next few days. Many individuals have selflessly devoted many hours and days to support vascepa approval and moving things forward. I would like acknowledge Zumantu@gmail.com for leading this effort and for all those who are contributing their time and effort in advancing vascepa usage and AMRN success and taking on the fight to FDA.
Please feel free to suggest any great ideas to make an impact on this message board or e-mail me at speedrunner199@yahoo.com.
I will provide additional updates on actions taken and provide copy of submitted letters and ask for help when warranted.
I also apologize for not responding to comments by the posters, I have been pre-occupied with the share count and working on other initiatives in progress. Once this is completed, I will answer questions or comments.
GLTALs.
Latest update on share count 11/1/2013:
Up to now 7:45 PM mountain time, I have total of 3,000,025 shares reported to me. I will continue the share count for 2 more days. Depending on the share count, I will then propose how we may affect influence on AMRN and would also welcome suggestions from the MB. Of course, higher the count the better.
I also want to thank everyone for sharing their share counts with me and for your willingness to participate in a unified front for a common goal. I also want to thank those who have shared their compelling stories and losses. I am aware of several initiatives that are in motion including a formation of a dedicated website, a letter being submitted FDA oversight sub-committee, contacting major media outlets, letter writing to FDA, major medical organizations and cardiologists. Some of this activities will be completed within next few days. Other possibilities that are likely to have major impact are also being considered (including legal action- although this does not appeared to be a good option)- all reasonable options are being considered. Please feel free to suggest any great ideas to make an impact.
I will provide additional updates on actions taken and provide copy of submitted letters and ask for help when warranted. We clearly want to have as much of an impact as possible- a major target will be the print media.
GLTALs.
Again, thank you for your participation.
Share count update
I would like to thank everyone for sharing their share count and willing to form a united share representation group. I am also touched by the e-mails that were sent and the pain that everyone has suffered. Some have lost millions, others lesser amounts but the loss has been deeply felt by all.
I have been in touch with zumantu and 23 other investors that have formed a group to form a unified response group. Zumantu is leading the effort and firmly committed to fighting this fight. Several initiatives are in the works and several others being considered. I would encourage any good ideas and would invite individuals with special expertise to join. We have several MDs and many talented individuals but we have a great need for individuals with law background and corporate background.
I am firmly committed to AMRN cause and believe in vascepa data and seeing through the Reduce It data.
I intend to initiate discussions on AMRN valuation and prospects going forward so that everyone can be better informed and make a rational investment decision. I think it would also be valuable for everyone to have an in-depth discussion on the science of vascepa and the likelihood for success based on scientific data. This is my strong suit and will be happy to share in this analysis. I think it would be constructive to look at the AMRN prospective in a level-headed manner without emotion.
The share count so far is 1,771,543.
Please provide me with your share amount if you are interested in a unified investor group to affect a
change or having a unified front. The more share we have, the more likelihood that we will be taken seriously.
Speed
Thank you for all of you who have provided the share numbers. I will keep the tally and update every evening. I will expand this effort to the Yahoo board.
I also appreciate the kind comments and also empathize with the pain that everyone is going through. At this stage, I think we need to do all we can in a calm and effective manner and considering all options that we could impact. It appears clear to me that there are many talented and high level individuals that are invested in AMRN, number of owners are MDs, lawyers, and those with experience in finances and investment. I think it is imperative that we utilize everyone's expertise and consider all input to try to effect positive change.
I do think the chances for changing the FDA outcome is going to be very difficult and an uphill battle. On the other hand, we should do all we can to try to affect the outcome. IMV, completing the Reduce It is of paramount importance as positive outcome of that study is a complete gamechanger. The valuation after Reduce IT outcome will be in excess of $10 billion market cap. I do agree all options for funding Reduce It must be considered, including NIH funding, partnership with profit sharing, or buy out that has conditional link to Reduce It study.
I do thin we need to decide the combined strategy in a calculated manner but take action relatively soon. At this point zumandu has agreed to lead this effort and my understanding is that number of investors are in touch with zumantu. I also welcome anyone interested in contributing or having a leadership role in this effort.
By the way, I am an academic physician.
Speed
To All posters interested in having a unified response and voice in AMRN management;
As I mentioned earlier, I think it would be very useful to to have a head count of the total shares that we control. If we control several million shares, we could have greater voice with the management and have some influence. At a minimum, we could have direct access t the leadership.
For information purposes, we have established a group of investors lead by zumatu to have an organized and unified response and action to FDA.
Please post number of share you own publicly or e-mail me in privacy to speedrunner199@yahoo.com and I will keep a running tally for everyone.
Thanks. Will start to keep track.
North4000,
Excellent info. Zumadu is leading and organizing an effort to respond to FDA. Your background would be invaluable to our combined efforts.
On question, how strong are the AMRN patents. Do you have any views on this. It appears solid but I would like an expert opinion. Please feel free to post or e-mail me at speedrunner199@yahoo.com.
Thanks for your help.
Back to work.
I am thinking that we could have 3-4 million shares. We could also elicit the Yahoo board to be included.
I will reveal my shares to Zu.
I agree he would be an excellent choice.
FYI, I have an extensive academic and research background and will be willing to contribute in a major way.
I also think it would also be a good idea to have a head count of how many shares we own. My belief is that combined, we may have significant percentage of the shares. If we combined the shares, we could also have a voice in the board or at a minimum, AMRN management will have to talk to us directly.
May be Zum can get a confidential head count through his e-mail account- if he is willing.
I do think we need an organized effort and get shareholders involved.
I will contact you. But, I also think we need to raise funds and get a headcount on how much people are willing to contribute.
I am willing to start a post to assess who is willing to contribute and how much. In order to do this we need a well formed response group and an identified leader with experience in this area. Some one like Akanz (who has corporate background) might be a great choice. To start things off, I am willing to donate $1000 to the cause.
I completely agree. The question is how do we organize and have a meaningful response that will have impact.
Is there anyone willing to lead and organize the effort to challenge the FDA or to facilitate a organized strategy to getting vascepa approved or seeing completion of Reduce It. I think we have to have a leader for this effort and organized effort to move forward- without an identified leader it will be difficult to organize unified response. I am very interested in helping in this cause. What do others think?
Zmanindc,
I fully agree with your view. Rather than complaining abut the terrible job the management did and how the FDA is making making a terrible decision, I think we should take some concrete actions that could have a real impact towards changing the outcome. If someone could step up and lead the efforts you noted below, I would be happy to support (both financially and in other ways) concrete actions that could actually impact the outcome. Is there anyone who is capable willing to step up and lead this effort and organize a response.
Good night to all and hope (and pray) for better days ahead for AMRN. This has been a most miserable year- hopefully, next year will be better.
Good night to all and hope (and pray) for better days ahead for AMRN. This has been a most miserable year- hopefully, next year will be better.
That is exactly the point. FDA had to do this to be in compliance with their guideline for breaking the SPA.
That is how incompetent the FDA is. Truly ignorant and incompetent, just amazing.
Another consideration is to have Reduce It funded in part the NIH, as was the case for fenofibrate. I think it would be critical to approach the NIH as they would very much want the study to be completed.
I completely agree. I didn't like their FDA request. It should have been just for lowering TG_ very simple, non-threatening and non-controversial.
I am surprised at how everyone is shocked at the announcement of FDA's notification. After the FDA vote question and outcome of the FDA panel meeting, the notification by the FDA was the only reasonable outcome that could have been expected. We need to stay calm and react responsibly to this announcement and take appropriate action, whether that may be selling the shares or doing all possible to support the company through the Reduce It trial. When the FDA panel voted no, per their guideline, FDA had to notify AMRN that they are reneging on the SPA due to change in science. This was required step to break the SPA based on FDA written guideline . Next step is for AMRN to request a type A meeting to discuss the breaking of the SPA and for further discussions on the matter. As far as I am concerned what happened was completely expected step that FDA had to take. Personally, I made the decision at the time of the Panel meeting that I will see through the Reduce It study. In my view, based on all the evidence that I reviewed there is still a very good possibility that the Reduce It study will show a positive outcome. My main concern is that they will not complete the study- to me this will be a disaster.
I do think that this is the time to take every action possible to let the FDA know that we the public disagree with their actions to renege on the SPA and put maximal pressure possible to influence the PDUFA outcome. Of course, this would be an uphill battle but as a share holder it is an action we can take that might influence their decision. I will be submitting my letter to the FDA expressing my disagreement with their decision tomorrow. I would hope that others do the same. This is the time to take stock and fight the decision not grieve. We need to do all we can to help vascepa get approved.
Although there is great deal of doom and gloom, there are good possibility going forward (if or when FDA gives a CRL) that a BP could partner for the Reduce It study or buy out the company at a bargain price- it would be a bargain price for great potential- the risk and reward may be compelling. There is also a possibility that the interim data could be overwhelmingly positive.
My point is that the actions of FDA were completely expected and logical. Our investment thesis must also be based on good rationale and our response also logical and appropriate. Although I wish we had a positive panel vote and FDA didn't violate the SPA, but FDA did and at this point we have to make a decision to sell or hold through to the Reduce IT. I am holding and I am fighting the FDA in what small way that I can.
Thanks.
Will contact.
Jesse,
Thanks for your input.
DRRC,
Glad to hear that vascepa is helping your condition. I can fully sympathize with you as one of the important complications of cardiac condition is ischemic bowel due to insufficient blood flow to the bowel.
Thank you very much for the corrections. Much appreciated.
Go seek , Annac,
Thanks for your kind comments.
I know it's an uphill battle but we should do all we can to help influence the outcome. Hopefully, the more letters we write, the more pressure we put on the FDA to to the right thing.
This is my letter to the FDA. I am posting for any comments to improve and also to share for others to use. I was worried it might be too long. I welcome all constructive input.
I am an academic center based gastroenterologist who specializes in both clinical practice and research related to obesity and inflammatory complications. With the current epidemic of obesity in the US, cardiovascular disease (CVD) remains the number one cause of adult mortality in the US. Although statins have had a major impact in improving CV outcome, risk of CVD remains high for many patients despite being on statin therapy. Previous studies have shown that elevated triglycerides (TG) are an important independent risk factor for CVD. These studies have shown that patients with elevated TG are much more likely to have complications related to CVD. Current recommendations of major medical societies including American Heart Association (AHA) and American Association of Clinical Endocrinologists (AACE) are to treat elevated TG levels above 200 mg/dl. In the most recent guidelines published by the AACE in 2012, guidelines state that “increasing clinical evidence suggests that elevated triglycerides may be an independent risk factor for CAD; therefore, AACE recommends screening of triglycerides as a component of lipid screening” and target “ triglyceride levels less than 150 mg/dL in both men and women are recommended (Grade A)”. Both AHA and AACE recommend treating triglyceride levels of 200-500 mg/dl with TG lowering agents “including omega fatty acids”. The current standard of care management strategy dictates that high risk patients with elevated triglycerides (200-500 mg/dl) be treated with TG lowering therapy.
Recently completed clinical trials (Marine and Anchor) have shown icosapent ethyl or vascepa to be highly efficacious in lowering TG in high risk patients with TG levels above 200 and 500 mg/dl without raising LDL-cholesterol levels. Moreover, the safety profile was excellent and favorable to other currently approved agents for lowering TG. Based on the published clinical trial data, vascepa has important therapeutic advantages over other currently approved medications for management of elevated TG levels in both safety and efficacy. Given the current recommendations by the major medical societies and the compelling data showing TG to be an independent risk factor for CVD, I urge the FDA to approve vascepa for treatment of TG between 200-500 mg/dl as the best drug in this class (best safety profile without raising LDL-cholesterol).
I would also like to express concern about the recent controversy surrounding the FDA advisory panel vote on the Amarin sNDA submission and the possible FDA decision to break the special protocol agreement (SPA) with Amarin. Amarin has fulfilled all aspects of the SPA in regards to the Anchor indication and sNDA submission. However, based on the FDA voting question and comments, FDA appears to have breached the SPA and appeared to impose a new requirement for the FDA approval. If indeed this is being considered, this would be a huge mistake for the FDA and such action could materially damage FDA’s credibility going forward. In my view, this breach and violation of the SPA is likely to have serious long-term consequences and could discourage new innovation and high risk development of drugs by small biotech companies. The possibility suggested by the FDA that “a substantial scientific issue essential to determining safety or efficacy of the drug has been identified after the testing has begun” is highly subjective and certainly has not been shown to be the case. The threshold level for such determination should be set at a very high level and any benefit of doubt should favor complying with the agreement. There were no substantive or indisputable evidence that were presented to show that vascepa reduction of TG would not lead to improved clinical outcome. All of the studies presented had major flaws in the design or did not study the high TG population. The only study to use icosapent ethyl showed a 53 % reduction in CVD related outcome, supporting the vascepa approval. In fact, more recent publications showing genetic linkage studies provide compelling evidence that elevated TG levels are an important risk factor of CVD.
In conclusion, TG elevation is an important risk factor for CVD and the current standard of care is to treat high risk patients with elevated TGs (200-500 mg/dl). Based on the clinical trial results of Anchor, which fulfilled all of the requirements of the SPA, I ask that the FDA to approve the sNDA for vascepa to be used to treat patients with elevated triglyceride levels between 200-500 mg/dl.
Excellent letter.
Trigliceride should be triglyceride.
Bio,
What does this mean?
Are you saying that AMRN owns the IP for epanova or am I misunderstanding your postings.
Thanks.
I forgot to ask that question. Hopefully, we will know more on the 3rd quarter CC next week.
Nomo,
I did not mean to mislead you. My impression from both CC and the reduction in force was in preparation for a CRL. I think given the 9-2 vote, AMRN believes the likelihood of approval is low. However, they were clearly wronged by FDA- whether by the director or the reviewer (Mary). They are in the process of pursuing all possible revenue to convince a positive vote. In this particular case, I also believe that FDA were way out of line. Hopefully, the public outcry- if intense enough- will pressure FDA to do the right thing- Conditional approval pending the outcome study.
She would be the logical scapegoat.
Discussion with AMRN investor relations. (I just posted this on Yahoo MB)
I recently had a long discussion with AMRN investor relations (Joe Brun)o and I would like to share the info discussed with the MB.
1. re FDA panel meeting: FDA never informed AMRN regarding the requirement of outcome study for Anchor approval or their intention to break the SPA prior to the panel meeting. They were completely surprised with the FDA’s linking outcome to vascepa lowering of TG. They have not given up on Anchor approval and will do everything possible to challenge the FDA requirement of outcome for Anchor approval- all options will be expended. These points were reiterated several times. My impression was that they also did not have any discussion with FDA since the negative panel vote but all options are being considered.
2. re Reduce-It trial: For now, Reduce-It study will continue and have been budgeted into 2014 revenue projections. The projected $80 million burn rate for 2014 includes the expense for Reduce-It study. However, decision on this could change after additional meetings with FDA. (I reiterated my position that completion of Reduce-It is crucial to future potential for AMRN and it would be a huge mistake to abandon Reduce-It).
3. re Finances: I raised a concern regarding decline in revenue with reduced sales forces. He felt quite strongly that based on their analysis and data on highest prescribing doctors and top revenue generating sales people that the sales growth will continue at a steady rate and that reduction in force will not have a major impact. He also felt that the continued sales increase will be able to support expenses and that no additional funding will be needed and that no dilution will occur. I asked about stock sales possibly in 2015 or 2016 but he was adamant that based on their projections they will not need to raise additional funds to complete the Reduce-It study. (I found this position to be very interesting and perhaps the cost cutting and increase in revenue may balance by sometime in 2015. I hope they are right. It is possible that with 80 mill burn rate in 2014 that additional revenue of about 80 million could be generated in 2015 to break even. I didn’t think this was possible but would be great news.)
4. re partnership or buy out: All options are on the table including partnership or buy out. Interestingly on this point, Joe was adamant that they did not need to partner to get Reduce-It to the finish line. (I was insistent that partnering would be a great idea to get Reduce-It to finish line)
Overall, I was encouraged that they are committed to challenging FDA on Anchor issue (but they seemed to think the probability of positive outcome was low). I was more encouraged by their more positive outlook on their finances. On this point I hope they are right and that they don't need to raise more money. Of course, they could be wrong. I am happy that they plan to complete the Reduce It study but was somewhat concerned that their discussion with FDA may influence this decision. Lastly, I think the best solution is to partner for the clinical study with a big Pharma or have a conditional buy out with a big Pharma. (Sale price of $1 billion now and $4-6 billion on FDA approval for Reduce It)
STS,
But these 2 are the individual responsible for the final decision. They have to be convinced and the maximum pressure has to go to them. They are the decision makers. PDA panel is over and they have no say in the FDA decision. Now, it's in Dr. Rosebraugh and Coleman's hands. Of course, as you suggest, pressure can be put by their superiors.
Speed
Go Seek and others,
I think it would be wise and helpful to talk to the company in how we can coordinate this effort to have maximal effect. While I appreciate your efforts, I think the petition and the letters could be improved by having professionals that specializes in this type of things. May be AMRN would be willing to have a "professional writer" and lawyer (Kennedy- AMRN legal counsel) review the letter and to improve the quality of the letter and the petition. Alternatively, we could establish a fund for you to use to have a professional writer help write the petition. I would be happy to contribute to such an effort.
Just a thought.
I appreciate all your hard work.
Speed
I just signed and included this in this comment in the petition. I am posting this so that those who want to post a comment can use portions of this information in their comment section.
I am an academic center based clinician who specializes in nutrition and treatment of obesity related complications. With the current epidemic of obesity in the US, CVD remains the top cause mortality in the US. Although statins have had an important impact in lowering cholesterol levels and improving CV health, an important clinical problem that persists is the elevated triglyceride levels in patients that already been optimally treated with statins. Moreover, many patients in our clinical practice do not tolerate statins well due to number of its well known adverse effects. For those patients with continued elevations of triglycerides and at high risk for CVD with multiple pre-existing risk factors, lowering their triglyceride level is an important component of managing their CVD risk and is recommended by most major medical societies. It is the standard of care in most physicians' practice to lower elevated triglycerides in high risk patients that have persistent elevations in triglycerides. Based on the published data, vascepa has excellent efficacy and safety profile to be used safely and effectively to lower triglyceride level. Given the overwhelming data indicating a correlation between elevated triglyceride and increased risk of CVD and the current standard of care recommendations to lower triglyceride levels in high risk patients, a drug such as vascepa that lowers triglyceride without increasing LDL cholesterol and excellent safety profile would be an important adjunct to statins in managing cardiovascular risk. Delaying the approval of vascepa until outcome study would deny this important adjunctive therapy to those patients at greatest risk to develop CVD complications. In essence, FDA would be publicly advocating against the treatment of elevated triglycerides in patients with high risk of developing CVD. This would certainly be counter to current guidelines and recommended standard of care. Given the current medical recommendations and standard of care practice, I ask that you approve vascepa for this important class of patients to treat high levels of triglycerides. A decision against vascepa approval for lowering elevated triglycerides would be counter to current medical recommendations and would deprive this high risk population of important potentially life saving therapeutic agent.
IMO that is wishful you thinking. If you read the the briefing document and watched the panel meeting it was quite clear what FDA was thinking. They want outcome data. As it is most likely outcome would be Anchor denial. However, this would mean they reneged on the SPA.
I think there is a small possibility that with strong public outcry and with future discussions with AMRN, FDA might be pressured for a conditional agreement- where negative outcome study would result in to withdrawal of Anchor indication. That could only happen with enormous legal pressure and public outcry.
Any info on scripts. Thanks