How about a new theory.....it starts with this basic premise that I believe....V and F work and that alprodastil does not lose it's efficacy when combined with nexact. That, there is a huge market for this and even amongst the younger guys who do not have ED. They can use it as insurance for when you put your drunk on. Now, why is it not on sale, the question that has been bugging me and I am sure all since Abbott.

Perhaps the deals they signed is really for the room temperature version and the wording in the contract gives them the rights to launch with the cold chain version. Perhaps nexact in the cold form is not stable, or too costly or too hard to store and that is why the partners are waiting. This way Apricus can say the partners are committed to the cold chain, not a lie but they know the partners are waiting for room temperature (misleading). I am not saying this is a fact, just trying to find a reason why this is taking so long. Saying a 2014 launch in the EU does not give me confidence it will happen because of all the false starts. Anyway, the above hypothesis may also be the reason why we have not seen a partner for just nexact.

Again, using depomed as an example, they license their digestive tech to companies that reformulate an existing drug and take it through the faster FDA 505b approval process. It's been 3 years for me, where is the touted potential of the delivery system?

I definately support this and we have two board members coming up for vote in 2014 that have been at the helm for Vivian Liu and the Warner deal, the bioquant deal, Damaj and the lil pharma deals, the contracts that seem to hold a mystery to the launch. That is Ray and Oppenheim and let's see if they disobey the owners of this company again by keeping them employed when they are voted out. When shareholders ban together they can facilitate change. I pushed them to drop the poison pill provision and while it was rejected for a shareholder vote on a technicality, the pressure and follow up I believe assisted in the decision to drop it. There are 3 things we need to do to reform this company and make it more attractive to the mutual funds.

1) A new board and at the very least, some new members with a clear path towards changing the board. How do we accomplish this..shareholder proposal to set term limits for board members.
2) Protect the voice of the owners/shareholders....amend the corportae bylaws to bind the board to all shareholder votes. If we vote on it they must accept.
3) Terminate the ATM and stabalize the stock. This does not mean they can't raise money. They are still authorized to register another 28 million shares and they can sell if needed through a secondary offering. None of this cash register strategy which lowers the value of the shares.

Put those 3 in and the funds will start buying. Stay status quo and we will never realize full potential with wallstreet support. I should add, none of this matters if a tube of V is still not on the market.

Great Job, and in addition to retweeting I will send your story to some of the folks at Fox news and Larry King for potential follow up. I think for Fox the lead in should be, before you become a doctor you need a law degree...why healthcare is so expensive in the US!

Anyway to reproduce the PR newswire story into a seeking alpha article? Seems we need a little financial press.

Where do we send our cash contributions for the marketing campaign?

I made a pledge and just need to know how to pay?

Great, I will retweet the petition site and include the epainitiative site. I got a few more people at work to sign and if I have to, I will post it in supermarkets.

I placed the petition under the community resource tab of WebMD almost 2 weeks ago. I also put it on drugs.com in a blog section, café pharma and on sparks health blog for men with heart disease. I think only email campaigns will work at this point.

This is very good, you should send it to the Washington Post, Washington Times and the Baltimore Sun, right in the FDA's backyard.

I tweeted the wrong petition...I sent the one that urges congress to take action on the FDA on behalf of Vascepa. When you search amarin on the petition site it only directs you to the new one for congress. I will try another strategy later.

I just finished tweeting the petition site to a number of celebrities that have a heart condition such as bill Clinton, larry king, robin Williams, Barbara walters, Regis, David Lettermen...for good measure I added Oprah, Dr. Oz, the doctors channel, katie Couric, Kelly Ripa. Not sure if it will work but I gave it a try. I don't have facebook and if somebody does posting links there might work.

What was the name of the fenofibrate the FDA just approved? Also, I forgot, which of the failed studies used fenofibrates? Thanks and appreciate any help with an answer.

In my opinion the company needs to keep a humble and professional tone with the FDA until they receive a final ruling. However, shareholders and patients need to take the fight to the FDA and the more noise we make, the more the FDA will look for a way out. They certainly do not want the pressure and publicity from average citizens. With that said, I still think JZ is at fault because he did not manage the relationship with the FDA. Had Amarin been in contact all along, and offering suggestions to the FDA on how to handle the info from studies used to terminate the SPA, the FDA would have worked with Amarin on a win win. Government employees want to avoid the extra work and scrutiny and here Amarin missed an opportunity.

In my opinion the company needs to keep a humble and professional tone with the FDA until they receive a final ruling. However, shareholders and patients need to take the fight to the FDA and the more noise we make, the more the FDA will look for a way out. They certainly do not want the pressure and publicity from average citizens. With that said, I still think JZ is at fault because he did not manage the relationship with the FDA. Had Amarin been in contact all along, and offering suggestions to the FDA on how to handle the info from studies used to terminate the SPA, the FDA would have worked with Amarin on a win win. Government employees want to avoid the extra work and scrutiny and here Amarin missed an opportunity.

I am not totally sure but based on my experience with prior investments, I think it's to study whether the drug has the potential to cause birth defects. I know they can test for that and I just don't know how long that takes to generate results. They have a longer road to travel in the US.

With government employees, the louder the bang and the more work it brings to them the better the odds of getting your way. Sad to say but that is how it works and it is not to say government employees are incompetent, or lazy. They navigate through a maze of politics and regulations and it is easy for them to misinterpret and or make mistakes. When that happens, they want to avoid the noise or extra work. Make it loud and force effort and we can win a compromise. The pain has to come from tax payers and patients...they can stonewall a company over short periods of time.

Thanks for the info and I will look into it. I will ask my cardiologist if it is ok to take with all the other stuff I have to down these days.

Lol, thanks for the advice and I do get my fair share of lean animal protein. It's just after suffering an MI and having stents my goal is to avoid bypass surgery. My numbers are great with the exception of the HDL. I think HDL might be an over rated target. I have hit 45 when my LDL is around 85 but the old recommendation is ldl under 79 for those that have suffered a heart attack.

By the way, always enjoy your posts.

I have been told it's genetic on HDL because I work out for 90 minutes 4 days per week, eat more fruits, vegetables and grains than any red meat and I get about 70% of my protein from plant sources versus meat. Do you have a suggestion on what I could add to my diet?

No, where did you see why they sold the shares through the ATM. I only read the sale and amount in the 10Q. I did not see an explanation as to why, when they have 20 million in cash they need to dilute for another $800k?

I read through the conference call minutes and will post more later. For now, did anyone hear an explanation or can understand why they sold shares through the ATM after the secondary....and at this low a price? Did they really need the $800k?

Hi Hypo, the soreness from the statin was reduced for me as well. I wish I could get my HDL numbers to your level and V has helped push my other markers lower. I also have a very mild case of rosacea and you might want to try Rosaderm or Rosula face cleanser (not sure of the exact name) I have a generic bottle and it costs $10.00. I also use metrogel for flare ups and they have a drug savings card.

I feel your pain and for the life of me can't understand why a large pharma has not tried a hostile right now. GSK just reported another drug failed clinical trials and the first one to grab up Amarin, in my opinion will strike gold. I would gladly accept shares instead of cash. At some point, this will get approved to reduce trigs, combo pill then reduce it results will make it the standrad of care for many years.

We are hurting right now because I do believe the CEO made 2 mistakes. First not accepting a fair offer with CV's and I believe he was greedy/over confident and 2) not managing the relationship with the FDA. Their action just feels like Amarin did not help them address the failed studies and instead kept touting the SPA.

They key for any patient and where Amarin should be heading is optimal therapy.

Optimal therapy is the lowest dose of any combination of medicine that produces the desired results. For example, to reach a target lipid profile it would be better to take the lowest statin dose plus Vascepa versus a higher statin dose only. Amarin should be full steam ahead on a combo pill and the blockbuster... a 10mg lipitor or 5 mg crestor plus 4g Vascepa for those with trig levels above 100 to 150. Note Trig not cholesterol and then up the dosage from there.

I think the AHA guidline is fine, their Excel tool is a stinker and I don't think any doctor will use it. But for now, based on all the scientific evidence they say lipid profiles need to be managed and they are not saying statin only. Low dose statin plus something safe that doesn't mess with your liver is a physicians dream.

Have they said the regulatory path for the US is the start of a PIII or is it NOT obvious?

It seems they do not have to do any background tests for cancer or toxicity so the question...do they have to go PI proof of concept, PII efficay or PIII efficacy with FDA guided endpoints.

Let's not forget Canada...under existing trade agreements and with a prescription, a US patient can import and buy a drug approved in Canada. That's why this delay on Vitaros in Canada is a real killer to the stock price. If Abbott would just get off the dime we would see millions in US sales.

It is not common sense and many companies partner a product right out of testing in a lab. It makes even more sense to partner when you have a longer, more expensive regulatory path. If you can't respond to me in a professional manner I suggest you ignore my posts.

Yes, it sounds better for the EU but my comment was on the US market and based on the language, it does not appear they can start at PII or PIII. I am also curious as to why they are waiting for the results of PDUFA. Perhaps they are looking at how difficult the FDA will be when it comes to the endpoints. If they want higher endpoints and reject the drug then Apricus knows what the hurdles will be for whatever phase they need to start from. Lately, this FDA is trying to regulate how doctors treat patients based on their recent approvals. It might be a better regulatory environment when we have new heads of the FDA, HHS.

It is not obvious at all, they would have announced it! They would say they are looking for a partner to develop and manage PIII.

Info on the other FSAD drug

http://sproutpharma.com/sprout-pharmaceuticals-confirms-resubmission-to-fda-of-flibanserin-for-treatment-of-pre-menopausal-hypoactive-sexual-desire-disorder/

http://en.wikipedia.org/wiki/Flibanserin

I can't tell, is it a pill like anti depression medication?

If the FDA required a PII or PIII it would have been in the press release. I think they have to go back to a PI, first prove efficacy points before they can move to the next trial. This is at least 3 to 4 yeras before it hits the US market. This is just based on the press release, perhaps they will give us a better idea on the call.

Are we sure it was them...they actually signed? Maybe they would be willing to tweet it or post it on their fan page. There are way too many nasty shorts and they will do anything to mess with this investment. You should see what they did to café pharma.

So what do we do, what would you suggest? Perhaps the state attorney general?

Go seek...see my suggestion on post number 21445

I just got the same reply and will fax it in the morning. We should all fax them....HHS does not need anymore attention....

Maybe Larry King would be open to pushing Vascepa if he knew it was super charged fish oil without the impurities. If Dr. Oz has a FB page and twitter it might help tweeting and posting the info to him.

If it makes you feel any better, 10k's are usually written to portray the worse and all possible risk.

I was hoping for a signed deal though and that is not the case.

Celebrity support for the FDA petition

I don't have a facebook or a twitter account but I understand you can tweet messages to stars or post info on their face book page. Below is an article on stars that have heart related issues, several including Regis, Rosie O'Donnell and Bill Clinton had/have CAD. They might support the cause. Below is the list.

http://www.huffingtonpost.com/2012/02/06/heart-disease-celebrities_n_1258409.html

http://abcnews.go.com/Health/slideshow/celebs-heart-problems-18345288

http://health.howstuffworks.com/medicine/surgeries-procedures/5-celebrities-who-had-heart-bypass-surgery.htm

Maybe Larry King would do a story?

Why on earth do you still sell shares at penny stock prices

This team has no respect for the value of the shares and with 20 million on hand did you really need that money? If you are confident in 4th quarter money why dilute? I think we are about to get setup again for the "wait until the next quarter" to be followed by that other APRI oldie but goodie "first half of the next fiscal year" I really hope I am wrong and they have a blockbuster to announce in the AM. Otherwise I spend the weekend writing shareholder proposals.

Take a look at the guidelines for those that experience a heart attack.

LDL under 79 and trigs under 100.....think you need a little help for that statin drug.....

Anybody see this story just posted on yahoo on new heart guidelines!

I don't see how the FDA can deny complimentary trig lowering therapies based on what Cardiologists recommend.

http://health.yahoo.net/news/s/nm/new-heart-guidelines-back-stronger-therapies-for-high-risk-patients

Is this good news for us?

By the way, since I had an MI events doctors recommend I keep my ldl under 79 and my trigs under 100. I can do that w/o a mega statin dose as long as the FDA allows me to keep my Vascepa!