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If you get a chance, post your experience on WebMD and drugs.com. You need to register in order to post.
Any doctors on our board that can post on Medscape?
You can post my patient testimonial that is on the website that goseek set-up. I went to post this morning but I feel funny putting my information on a site that is dedicated to healthcare professionals, only. I posted on WebMD and drugs.com under the heart section. I would encourage others to post testimonials on these sites and any others. It would be good to have some testimonials for arthritis, diabetes and dry eye. I put mine under cholesterol, statin use.
Those that take Vascepa please join me in efforts to get the word out.
I posted on several mainstream sites about my experience and realized benefits with the drug. I noticed on sites such as WebMD you can post in different forums like dry eyes and others for arthritis. If you take the drug I would encourage you to search out the medical and drug blogs and post your experience. If you use it for dry eyes post there and etc. As patients, we can't rely on our doctors to stay up to date on the latest medication. We need to educate them and the more we can reach patients, the higher chance we have to drive sales.
I would have to agree with this author
Amarin did not manage their relationship with the FDA and based on their actions, someone must have made them mad. Amarin should have worked with them after each negative study was released and should have also asked the FDA if they wanted any other tests or on-going measurements for markers cited in the positive EPA studies. Somehow they stood behind the SPA and I do not think they did anything to help out members of the FDA. Keep in mind, its nearly impossible to fire a federal employee and most only care about how to lessen their workload. If Amarin compromised their relationship the employees can do whatever they like and even if Amarin wins in court, nothing will happen to the employees. I would say fire Joe and put someone humble in there to negotiate.
I already emailed your earlier version with a few edits.
I included suspicious trading activity and sent this on Thursday. I have not received a reply or acknowledgement of the email. Of course I signed it under my name.
Interesting chart, does it capture naked short sales?
It just looks to me that the intentional walk down was of the naked variety with an up day on the 4th. It also apperas based on the open short position that someone is trying to cover but only getting 10 to 20k shares covered. Hopefully, we see roasted short next week.
It's also cover day for the firm(s) that are using a naked short startegy.
I suspect today to close near 1.80 as they cover.
I just think we should be ready to act quickly
Prior to the type A meeting and PDUFA date we should do everything we can to let the FDA executives and congress know this is a patient rights issue and the drug should be approved. If they reject or delay, the very next day we file citizen petitions and any other actions. We need to act fast and overwhelming which usually makes the government types pause...they want to avoid publicity, scrutiny and extra work. Any action has to cause all 3.
The truth is government agencies are sued all the time and they lose more than they win
They do not have unlimited resources and rely on staff attorneys, no third party help and they are usually overmatched by private sector attorney's. We can sue, we can win but taking actions to court does take time. It's best they (Amarin) should ask for a criminal investigation while they attempt a civil remedy. They should also file a complaint with the office of inspector general against FDA abuse.
Just let us know what the procedure is we can file multiple petitions
Lets go after all AZN drugs and any other cholesterol lowering medication.
lol,I am an optimist and the one trying to shake up management
I will be very happy if they announce a clear and measureable development path with a partner. But, that has to come with launch dates for Vitaros. I just hope it's not a bunch of just wait until the 4th quarter.
Suggestion on the Petition
It looks like we are building momentum again and may I suggest you wait another week before sending it out. It appeared we had quite a few anonymous signatures and I think the more names the better off we are. Some of our direct efforts are paying off and perhaps we can hit 2,000 if we wait a week.
FYI, FDA replied to my follow up question on Femprox
Again, no news and nothing new see below
Any information on an application, including information specific to any meetings surrounding the application's review, that did not receive approval or has as yet to receive FDA approval, belongs to the manufacturer/sponsor developing the drug. Therefore, this proprietary information is not releasable from the FDA.
Best regards,
B.C.
Drug Information Specialist | Division of Drug Information Center for Drug Evaluation and Research | Food and Drug Administration
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.
To: CDER DRUG INFO
Subject: Re: FDA Meeting Minutes for a drug called Femprox
One more question, if a drug company holds a meeting with the FDA, does the FDA produce minutes of that meeting. If they do, is that available to the public?
I emailed and signed this letter.
I also added potential violation of the SEC rules for insider trading.
I have 19,500 shares at a average cost of $4.59
In it for 3 years and I am sick too. No sense in wasting energy right now and lets see what they have come Wednesday. If it is the same old song and dance I promise I will join any effort you put forward and I will probably lead a few efforts of my own.
Are you referring to my last post?
Then let me rephrase, would anyone like to join me on Monday for a spirited defense of our company and investment against potential slanderous remarks? Remarks that perhaps are made by a member or members of an organization that would like to see our stock value drop to zero.
Is this ok?
On a lighter note
I am off from work on Monday, anyone want to help me bash the basher. I can think of a few new ways to spin him out of control.
I don't think the minutes are a material event
The FDA either said redo PII or here is the path to take for PIII. It becomes material if the company has Femprox booked as an asset and the FDA (which would not happen)came back and said the drug in its form would never be approvable. It is material if they have a partner and a signed agreement for Femprox. If its just notes for PII or PIII they can sit on it for as long as they like. It stinks but I am not really concerned about the minutes. After 3 years I want results.
Just a few lawsuits against the fda
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/lawsuit-against-fda-over-vyvanse-nce-exclusivity-put-on-ice-while-fda-solicits-public-comment.html
http://www.hpj.com/archives/2011/sep11/sep19/0902DelMonteSuesFDAsr.cfm
http://www.benzinga.com/news/12/09/2939676/depomed-files-suit-against-the-fda-seeking-grant-of-orphan-drug-exclusivity-for-g
The one above should sound familiar.
We have been waiting over a year for these minutes.....
If what is in it is not favoareable then we have cause for a class action. I cannot believe they would sit on this for over a year! What's the secret....or was Damaj fibbing?
I will send my blood panels this evening when I am at my home PC. In the meantime, you might want to post the website on the resource section on webmd.
You can post these lipid tests, before and after.
You can also post my state on the testimonial which is Maryland.
If you give me your email I will send you my lipid file. It will not format in this message.
Been in this stock for 3 years and I am drawing the line at this call.
If you have been here for at least two years you understand that when they say fourth quarter, it means they will move it to first half of 2014 and dilute us in the first quarter of 2014. Two years in a row!!!!! No more and I am giving them this conference call.
Wow, I will send it this evening..what about the attorney general or any senate oversight groups.
Do you think we should send this to the AG for NJ and perhaps the Irish consulate? With the funny trades that went on there has to be some type of fraud.
How do we come up with a citizens petition?
You know what else fits 4 days????
The fourth day is when this degenerate short covers the naked position. These firms or firm has worked really hard over the past two months to bring the price down. It does not look they were able to harvest enough shares to close out their short. Unless topotarget is unloading and they found a significant chunk in these sales.
DG, I hope it does not come to this but if we get the same old song and dance next week, I hope you will not censor my attempts to organize shareholders to go after the board. We can't let them feed us a line that everything is the end of 4th quarter....how many times have we heard next quarter. We need to draw the line in the sand, they have had plenty of time to sign deals, negotiate launch dates and do something to add shareholder value.
I will post this evening, when I mentioned "we" I was referring to any others that felt like posting.
Right now and in my opinion, Amarin management needs to keep a cool and open negotiating posture with the FDA. They can unleash armegeddon when and if they receive the CRL. However, shareholders and patients should take an active role in getting the word out and taking the FDA to task.
What is the FTC violation?
I will be happy to send my complaint.
I will send it to Amarin and start researching how to get it into the hands of the funds.
Does anyone know how we might be able to get access to the patients? It seems we have at least 6,000 Vascepa users and that would help.
Suggestion for the petition
Have we sent it to some of the institutional investors that own Amarin stock? Did we send it to amarin to have employees sign?
There is another Vascepa website called buyvascepa.com
That site does not contain any testimonials. Maybe we can post on the cafe pharma and have the amarin drug reps refer patients.
Signed Agreements?
Not to be an alarmist but after checking the SEC site, if APRI has entered into any agreements they must be disclosed within a certain number of days. I am not sure they have a signed agreement for anything at the moment. I think the rule is 4 days to disclose a material event. I am not sure if an MOU is a material event so perhaps they have a few of those and working on final agreements. As of now, I don't believe they have a signed deal. Anyone else on SEC material disclosure?
Huffington Post
To those organizing our response, have you considered sending info to the huffington post? Also, I think Ralph Nader has a group or a blog where we can post material.
I am just shocked how every bit of news has been anti amarin and nothing on the dangers of this action by the fda, the implication of their action on healthcare costs and the US Biotech industry nor the harm to patients by denying access to a safe drug. Yes, it is denial becuase now insurance companies can lower coverage or not cover off label at all.
Not too sound paranoid
Be careful what you post on this site because I think the shorts try to undermine our efforts. My two posts on WebMD and drugs.com were removed. They can only be removed by someone flagging them. It is unfortunate that these degenerates would censor information that is valuable for heart patients posted by someone who is a heart patient. All I can hope is that what goes around comes around and justice will be done to them; in this life or the one thereafter.
Swiss Medic was a negative
It again called in question the issue of shelf life and was the last catalyst contributing to the downward spiral. Do I think it's a big deal...not really. Was it further ammo for shorts and another question mark keeping larger investors from jumping in....yes. Right now, none of us really know what the issue is with shelf life. I have checked every alprodastil ED product and they all require refrigeration. I just don't see why this is a hold up on any of the launches. Unless Apricus management told the partners that room temperature was right around the corner..we just don't know. It's 3 years for me and I only had one shot to sell at a profit and I was dumb to buy into what management fed us. Now I sit with a huge paper loss and don't give me the garbage about averaging down. It goes against the peter lynch principle and the stock can go lower. I am giving them until the conference call and then we will see.
It would be nice to see the swiss medic approval resolved
That was a big negative and I believe might have slowed the marketing approvals in some of the other territories. We need to get that behind us. Anything on Russia or China? Whatever happened to the mideast approvals...it takes two years?
I thought the topotarget shares had restricted sales window
I would need to go back and read the filing again but I thought the shares were issued with restrictions. I would think one of those restrictions would be X number of days before an earnings announcement. I sure would hope we are not selling shares off the ATM. I could not see any rationale reason why this company would need more money. Just get your partners to market.
I am not sure how to interpret it.
One thing I am sure of and despite the BS from the shorts, the FDA cannot reject Femprox. Femprox does not have a regulatory milestone for the FDA to reject. They will either guide Apricus to redo Phase II or provide them with the guidance for Phase III. What I care about more than anything, do we have a partner that will manage and sponsor the Femprox clinical trial? If we do then shorts are toast. Oh, and when will Abbott give canada a stiffy instead of stiffing Apri shareholders.
This is not a technical breakdown
We have almost no institutional support and what these shorters are doing is trying to scare retail to sell and trigger stop losses. They walk the price down through naked short sales and then cover before they run into the violation period. This has been going on for months. What they have achieved is bring the price down slowly over this time. Watch, within the next 3 days it will pop back up, probably 1.80 to 1.90 on nothing more than a naked short cover. The only thing that has me confused is why we are not seeing a steeper decline in short shares (cover). It might be possible that they have only been able to harvest enough shares to cover their naked short raids. Just my opinion and from what I have observed.
You can find 18 testimonials for this drug on WebMD. Two are from what I believe to be a short and the rest sound like real users. 5 posts are from users like me that are off label and the rest are high trigs. This drug performs as advertised, at least for me. I tried lovaza when it first went on the market and could not take the bloating plus it increased what I was trying to decrease. No issues at all with this drug. It's crazy how some pump OTC fish oil when we get constant warnings about the impurities in OTC supplements. Very few passed consumer reports tests and the brands that did are just as expensive as Vascepa in the high dose range. Vascepa is cheaper if you have any type of insurance.
Public Citizen Commercials
For the many of you that are doing a great job organizing our efforts I thought we might look into advertising our message. If we form a non profit, something like citizens for better healthcare we might have access to public service announcements and raise funds to advertise. We can solicit support for the petition and promote Vascepa. This way the company would not run into any issues with the promotion of the drug for off label use. We can just use patient testimonials.