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Twitter updates
If anyone has a twitter account, can you tweet out the request to sign the petition and URL. I don't use Facebook but was wondering if you can add the link to the petition on your account. I think we really need several thousand to make it stand out. I wish we had access to all the Vascepa users, that would definitely help.
I submitted my testimonial.
For some reason my posts on drugs.com and WebMD were deleted. I will post again this evening and I encourage others to do the same.
I will post this evening and even include my lab results.
I am not sure it works that way for Raynaud syndrome
Vitaros is a distinct application and so is Raynaud and it would require seperate approval from the FDA. For example, have you seen the commercials where they are now using antidepressants for pain? To market to those with pain requires a seperate trial for efficacy. The formulation of the drug, dosage would be different for Raynaud versus ED. So the real question is....what happened?
Whatever happened to using Nexact and alprodastil for Raynauds Syndrome?
That was about the time I was into my first year of ownership in this stock. I forgot, didn't they receive fast track or orphan drug status? This could have been huge and think about the application with diabetes. They could not find a partner willing to develop it? Or a grant from one of the many diabetes foundations? Anyone recall some of the other drugs they mentioned (not Prevonco)?
I signed and got a bunch of people to sign so I'm good. I do like the idea of our own dedicated website. Let me know if anyone can build it and what I can do to help.
You have my permission to add me to the list, how do I sign up?
I would contribute my story and test results to an independent site.
I think that is a great idea and one thing that frustrated me in my online search is the number of links and pop up ads for lovaza. I only found one vascepa link and the website...buyvascepa.com.
If you know of more sites let me know and I will post.
I have 4 favorable on my WebMD posts. I added comments to a healthy living article and one on men's health but I need more sites where heart patients like myself post. I only found WebMD and drugs.com was a bonus. By the way, we should see if the person that runs the site buyvascepa.com will let us link the petition.
Vascepa users, we need to post our experience with the drug
I just finished posting a review of my experience with Vascepa on drugs.com. I also added it as a message board topic for lowering trigs and easing the aches from statins. I started another thread to link support back to the FDA petition. I did the same thing this morning on WebMD. As users, we need to get the word out and educate patients. They will ask their doctors and can act as the stealth sales force. In addition, add more names to the petition. Does anyone have a list of sites we can post on? I tried Harvard and the Mayo clinic...nothing. You can't post anything on the American Heart Association site. We need to go site by site.
More Help- Just posted This on WebMD.
If anyone is familiar with other sites dedicated to treating patients then please feel free to post this. If you take Vascepa you should post your experience. We need to educate potential patients and enroll their support with the FDA. You can see my post in the Heart disease community.
What I posted
I actually use this drug at 2g and previously tried Plusepa and Krill oil to lower my triglycerides and ease the muscle pain I have by taking atorvastatin. I also tried OTC Niacin at 750mg and COQ-10 and all I was able to gain was a case of reflux. I stopped taking all the supplements and the reflux went away but not the dull ache from the statin. Then I heard about this new prescription drug Vascepa. After educating my cardiologist he gave me a prescription and I started this drug in June. Within 3 weeks I was virtually ache free and could lift weights and I am now working out 3 days and sometimes 5 days per week. Pain free and my entire cholesterol profile is down on average 9% since my last test and even down compared to a year's worth of tests. My Cardiologist let me know that if my test results remain the same on my next visit he will lower my statin dose to the lowest level. It has taken over 2 years to get there and adding Vascepa did the trick.
Vascepa is a highly purified and prescription grade drug made from fish oil. It is unlike Lovaza and contains no DHA or other acids. Vascepa (icosapent ethyl) capsules are the first FDA approved EPA only Omega-3 fatty acid. Vascepa is a prescription medicine, used along with a low-fat and low-cholesterol diet, to lower high triglycerides (fats). You can read more about Vascepa by visiting their website: http://www.vascepa.com/ you can see a comparison of Vascepa against Lovaza by visiting this site: www.buyvascepa.com. Unlike Lovaza and other fish oil supplements Vascepa does not increase LDL Cholesterol or carry Afib warnings. Vascepa side effects are comparable to a placebo.
I could also use the help of this community to please sign the petition that is linked below.
Recently, the FDA indicated it would not approve Vascepa for those on statin therapy with cholesterol levels from 200-500. The FDA rationale seems to be contrary to what our doctors are telling us that "lowering triglycerides does not produce fewer cardiovascular events". The FDA wants proof that lowering trigs reduces CVE events and requires results from an outcome study that is underway. The results of this study are expected in the next 4 years. In the meantime, the actions by the FDA limit drugs available to treat those like myself who suffer with atherosclerosis. These limits are in the form of prescription coverage our insurance company will allow. Right now I have Tier III coverage but these actions might cause my insurance company to drop coverage for my condition. Further, with all of the new regulations doctors do not have time to educate themselves on the latest treatments and drug companies actually perform a service when they can market to an indication. Don't let the FDA take away your ability to add a safe and effective drug to your treatment. The details about the drug and the misguided action of the FDA are contained in the petition.
http://www.thepetitionsite.com/176/817/515/urge-the-fda-to-approve-vascepa-for-mixed-dyslipidemia/
Is anyone sending our story to the major or big market news outlets?
The one in the DC area is 7onyourside@wjla.com. They have aired a few critical FDA stories over the year. Perhaps we can send it along three story lines:
1) FDA attempts to regulate MDs through policy
2) FDA ignorance and arrogance may cause the loss of the US biotech industry
3) FDA when regulators care more about track records than people's lives
4) Does wall street receive inside info from the FDA (suspicious trades)
We should send them a copy of the petition and all the letters that were written.
Biggie...I agree with everything except meeting with funds. If you don't have anything to tell them why rehash the same stuff. Until a drug is sold or a partner(s) are involved in a clinical trial for Femprox it's just a waste of time. This company does not have credibility right now and the only thing that will change that is for them to execute....of course changing the board will also help.
I know and I am withholding any action until after I hear them out in November. I think you would agree that we should hear some measureable progress after 11 months. Progress is cash payments, a clear implementable plan for Femprox with a partner or an actual launch date for V.
I for one could care less about promotion and believe in results. Get your products out there, create a plan and meet your milestones. If you do that you don't need promotions. One correction DG, the action to sell the oncology drugs is a bit tongue in cheek...it was more like dump the companies without paying someone to take them.
Then there are examples like Omthera where pharma will buy a company that is still in the regulatory process. If they have something of value, a Pharma will buy them and the earler they buy the better the price. I don't totally disagree with what you are saying, it's as reasonable as other explanations. Right now, it still does not add up....all this time and the silence. I am also not sure big money will come into the stock. I think that little game the board played with shareholders votes will haunt them until we can get them out. If you are a fund manager, do you want to committ millions to a company where your investment carries no vote? What they pulled is extremely rare and I am hoping we can clean up the board real soon.
Now that I thought about this.....without the poison pill if Abbott really wanted the rights they could buy the company for less than the full value of the license and royalty fees. I think it might be something else...what that is only management knows.
Silly question and I guess owning this stock makes you think of crazy stuff. Since the delivery mechanism is transdermal, if you rub it in will it not increase the blood flow to your fingers or palm? Now I thought of a funny......is that how one get's a rosey palm?
What happened to the link for the petition?
Did we send it already or are we still looking for signatures?
Let me see, you are saying the tender means the ability to license the remaining global rights?
I hypothesized long ago that I thought Abbott was dragging as a way to force the company to renegotiate the deal, or buy it outright. Now I just don't know what to believe. I would think that we would hear of a UK or German launch date. That is why I am now thinking maybe there is something to a potential product issue. I was shocked when I saw the eye dropper instructions for V and always thought it was a rub on. That was new and I had asked cox 2 years ago about getting a copy of the Canadian label and he gave me a story. This was before Abbott signed on.
With the discount card I paid $75 for a 90 day supply at 2Grams and I swear by this drug. None of the OTC stuff like Niacin at 750mg or the varieties of OTC fish oil and krill oil that my doctor said to try worked. The only thing it did was give me GERD and add Dexillant to my daily drug regime...now....no heartburn...will be dropping to the lowest statin dose and almost pain free. The FDA = Federal Death Administration.....I knew we had a death panel .
I am not sure I understand...what is "for Canada i still believe they r waiting the tender results before any step". I appreciate the clarification.
If they launch in Canada the trade agreements allows a us citizen to buy Canadian drugs with a prescription. That would make court very happy .
If you look at how Cialis is now positioned I have no doubt that alprodastil, with continued use might help those with urinary problems. Where the company and any partner will get bogged down is that at least the FDA will require a long-term study to prove it.
If you want to see some of it's potential just look up ED treatment and the Boston Medical group. All that firm does is push alprodastil injections for almost any male condition.
If you want to see how a bio tech partners it's drug delivery system while keep some drugs for self-marketing you can look at Depomed. Not to buy just as a strategy APRI could have or should have in place.
Whoever cincyreds and docinvestor that post on the Y board seem to be doing a good job at organizing. I signed and forwarded the petition.
I am not only a concerned shareholder but concerned patient. I use this drug outside of the approved parameters and this action by the FDA might end the Tier III coverage I have with BCBS. I do agree we need to wait for the final outcome before taking any legal action. In the meantime, writing all parties in congress, the head of the FDA and HHS will help. Any kind of publicity might amp the pressure for a face saving solution.
Keep in mind that the company has to play nice with the FDA until they exhaust all avenues through negotiations. For one thing, the FDA could give them the green light for all trig levels not on statin therapy. While they play the FDA game shareholders can take them to the wall. Heck, as taxpayers we should take them to the wall, they are killing US drug innovation and increasing the cost of new drugs.
I could respond in kind but why bother. The proof is where this stock sits at the moment and the amount of institutional ownership.
Some suggested next steps...
I intend to write my congressmen/women about this. Sometimes these government employees want to be known for a legacy before they retire and with no repercussions, can take almost any action they please. Keep in mind they might have thought this would fly under the radar with all the issues around the healthcare website. What we could do....
1) Find a lawyer to sue the FDA on behalf of shareholders and we can use the gofundme site to obtain donations for the legal action. We would get plenty for fighting the government.
2) A shareholder petition to the FDA stating we support termination of reduce-it....it would be seen publicly as their fault.
3)All of us need to write congress and if we can, news outlets. This action is a killer for many new drugs and non statin cardio trig treatment. Will every drug require outcome studies....how much extra will that cost?
Good news and not so good news from the FDA
Below is the response and I did not find a smoking gun. I did reply back and asked if meeting minutes would be available to the public. I will post that response. The bad news, we have to rely on the company for info and I can't confirm anything regarding Femprox.
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).
The sponsor, or drug company is the only entity that can disclose where they are in the drug development process and when they expect to receive FDA approval. Any information on an application if submitted by a firm to the FDA that did not receive approval or has yet to receive FDA approval, belongs to the manufacturer/sponsor developing the drug (21 CFR 314.430). Therefore, this proprietary information, including clinical trial 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
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Eicoman initially informed me of the criteria to be eligible for an SPA and I confirmed that through the FDA site. It's possible the FDA changed the criteria for an SPA and I believe Biosante would have secured that SPA almost a year before they even started PIII. I think an SPA for Femprox, given what I found is unlikely. That does not mean it will have a harder time towards approval, it will just not have an SPA.
I thought libigel was not denied for safety by the FDA. I thought biosante could not submit it for approval becuase it did not show enough efficacy to offset the potential issues of using a hormone (testosterone). I thought biosante terminated the trial, but I could be wrong.
I am waiting for the next conference call. However, that does not mean I should just sit around and wait. I am going directly to the FDA to find out if they held any meetings with APRI. If I have to, I will fill out the freedom of information act form. Three yeras of broken promises and stale investment along with losing my Y handle to a short is driving me to be action oriented. This management team should not take shareholders for granted.
I just sent a request to the FDA to ask how we can find the meeting minutes and/or, at least confirm a meeting took place. I will wait for the conference call update and if it's the same old song and dance, I think it's time we submit a variety of shareholder proposals and force these guys to come clean, or force them out. It's now year 3 and its the same story every year.
The FDA is really good about posting information regarding regulatory meetings. I am going to email them and ask if a meeting took place with Apricus. I will let you know what I find.
The problem is that you can't wait too long, you have a minimum number of days in which to submit a proposal. Waiting until January is cutting it too close.
Why would you be against exploring a sale....shareholders will be able to vote on whether to accept a bid and if we really have the goods I think we would receive an offer of $8.00 or more.
I just don't trust these guys anymore. Too many common directors, management and agreements with Innovus. Too many missed deadlines, more questions than answers, two failed acquisitions (bioquant and the latest round of failures)3 CEOs in 4 years. I almost forgot, whatever happened to the V applications in the middle east and the two announcements over 3 years about plans to file in Latin America? Do you know what's common in all of this....the chairman of the board...Rusty Ray and he definately needs to go!
I have not sent any recent proposals. Last year they rejected my poison pill termination on a technicality. This year I will send it early and like I said, mid November if nothing happens then I think we should all submit proposals.
I still think if V works...and I have to believe that big pharmas would not license a product that didn't, the stock is worth closer to $8....$320 to $400 million. What I fear is that management is not telling us something about the shelf life and all along these pharma companies had the right to wait for room temperature. Don't also rule out the take under to take over by management. I would take $5.00 though just to end the madness and not lose money.
A few powerfull institutions would definately help but I think if the BOD continues to ignore shareholder votes they will open themselves up to potential SEC violations. I researched this last year and need to do my DD all over again to find the SEC rules governing directors and shareholder rights. This year Rusty Ray, Oppenheim and perhaps Pascoe come up for voting. I really believe something positive will happen before the next vote. If not, no way these two to three are reelected. If the board again disregards shareholder votes it could open them up to a class action suit. I am going to give them until mid November and if no news then I plan to submit another shareholder proposal. Last year I submitted termination of the shareholder rights plan (poison pill). I think I will pick one of the following:
1) The board will be bound to accept all actions approved by shareholders.
2) Cap shares outstanding to 50 million and require shareholder approval for the sale of shares above 50 million. ( I believe the current threshold is 75 million).
3) Term limits for board members, propose 2 2 year terms.
4) Hire independeent firm to pursue the sale of the company.
Those are just a few I can think of. It is really frustrating when you think of how much time has gone by without the sale of what could be a game changer in the ED market. That does not even address any possible partnerships in moving drugs through the Nexact platform......they could not find one company that would have been willing to fund a trial for Prevonco?
Maybe I miss read one of the press releases early in the year, I thought Canada had an approved version with a shelf life much longer than the EU. That is why I was so skeptical of managements position as to the delay. Does anyone recall the press release I am talking about?