These guys backs are against the wall. I don't know which company/companies they will have to bolt on but it is clear that it will most likely be more than one. Hopefully we are one of those.
It certainly becomes a valid patent but they will wait until Anchor approval before listing in the OB. See statement below
Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent and the anticipated approval of Vascepa in the ANCHOR indication
Thanks for the info Williams. There are some golden nuggets of insight about the CDER and their workings. GLTY.
Excellent DD Kay. Glad to come in from spraying weeds and seeing an excellent quality post.
You stole my thunder with your above post concerning payback if BO by Dec 31st. IMO this seems very unusual (although not rare) to put such language in a loan. Look over as many documents as you want and you'll come across only an occasional document that mentions this type of post. Of course if we do have a BO BEOY, then Pharmacon will make only a measily 40% on their one year investment. LOL. Pretty shrewd deal for Pharmacon both ways IMO. Good deal for us if we have a BO pending, a little expensive on the interest side if we GIA or partner.
On a side note, if you look a application # 13/266,085 which is our parent patent for the the combination drug, we've hit a little bit of a snag. The FDA has put a retriction/election on this patent app. Now here is the interesting part. The reason it is so broad is that we have opened it up to any and all statins and not specific on what cardiovascular condition it will treat.
The FDA is requiring us to name a specific statin and a specifc cardio dz that it is treating.
We basically have 30 days to reply which means we will have to report by April 13th on these two issues. If it turns out that we are going with rosuvastatin which it appears that we might from the child patents the I don't know any way that we can do that with Crestor not coming of patent exp until 2016. If it is Rosuvastatin then AMRN will have to show their hand as AZN being the behind the scenes company that they are working with because only way they could use Crestor with Vascepa is through some agreement of some sort since still under patent.
If it is Zocor, lipitor, etc then the jury is still out who/what is being considered. JMO. Thx for the good Sat read.
Excellent news Cov and Kayla,
When you post Kayla, I know the research has already been done. Thanks you two. Options may be a little more interesting tomorrow now:-).
Williams is putting his research and DD out there. He could easily keep this info to himself but he chooses to disceminate the information and thus help us at the same time. It is up to each of us to decifer the information from what some may consider overexuberance and determine how it applies. I think he is on to something with the FDA and USP in defining the names of the active moeity and how they will be listed. We just may have to wait a few more months. Most of us have hd our share of being wrong in what we thought might happen. I thought we would get NCE in November and then in Feb and was flat out wrong both times.
One small fact that he showed was that a 5052b does require some type of patent to back up the NDA if the publications (as was in our case) were not those that satisfied FDA requirements. This in itself created the first delays. What is holding it up at this point however is still a matter of speculation. Keep putting your ideas out there Williams. I think Tommy was wrong 99 times before he got the lightbulb to finally glow for a bit:-).
That is a heck of a lot of digging and sleuthing. I'm pulling for you all the way! There is certainly areas of finality that are taking place. I hope to dig a litttle into thismyself. It's sping break this weeks so it is bascally work and family right and not much time for detective work. Thanks for all your contributions.
Thanks Subs. I also spotted a Pfizer manufacturing facility about the same distance. I guess it would be pure speculation who they were working with. Appreciate your DD.
They're accumulating. At the analyst conf in October, the Dr over LI-1 said he expected initial study results after easter. I know Swisher says 1st half. I expect it earlier than later.
If L1-1 100 person arms (50 in each) are extended to 100 each arm, we are significantly derisked and go over 9 bucks very soon thereafter IMO. All the analysts will be reevaluating their TP.
I sure wish I could catch a few breaks with AMRN so I could settle in soldly with SNSS again. High probability that we at least show a 20-25% increase in life expectancy. JMO
I very much appreciate your insight nukem. thanks! Your opinions are spot on IMO. I have tried to look at the NCE issue through many angles and the more I look, the more I realize that it could go any way. If I knew whether they were taking a structural or chemical approach would help but even then no slam dunks one way or another.
Someone posted months ago that Dr. Goldenberg was involved in some fashion with the initial FDA discussions concerning NCE and Vascepa. I WISH SOMEONE WOULD VERIFY THIS. His comment still seems the most feasible if you are taking the side that we get NCE:
The active moiety in GlaxoSmithKline’s Lovaza, a similar agent for the treatment of hypertriglyceridemia, is a mixture of omega-3-acid ethyl esters that includes icosapent ethyl (EPA), docosahexaenoic acid (DHA), and a few others. Without requiring GlaxoSmithKline to specify which ester helps to lower triglycerides, the FDA considered the mixture of EPA and DHA as the active moiety that is responsible for the physiological and pharmacological action of Lovaza. Vascepa might have an advantage over Lovaza; it does not increase LDL-C levels, which has sometimes been observed with Lovaza.
The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act.
What might have saved AMRN is that the FDA did not require GSK to be specific on what the active moetiety is leaving the door open for Icosapent Ethyl.
I did find that Pfizer does have a global engineering plant near bedminster new jersey in a town called peapack so at one time it seems apparent that they were involved in helping us in the manufacturing side in some form or fashion.
Thank you for your searching and digging.
For those interested, here is Pronova's Corp presentation from March 2011.
The reason I am posting is that it appears Pronova had the same plan in place as AMRN back then on developing a NCE approved Omega 3.
Remove the words dot and the stars.
Look at page 27 and 28 and see that their plan was to form derivatives of Omega 3 FA as may have been accomplished with Vascepa.
Now that they are part of BASF then hopefully they will be friend and not foe.
Also look on page 30-33 for a good summary of pros and cons of currently used drugs for mixed dyslipidemia. It's a good quick guide.
Finally a question to anyone that might know. Is there a drug company near AMRN offices in the Jersey area? On the FDA posting yesterday, they did a great job with blacking out everything and not giving hints in most area but in the API and testing area, one of the facilities blacked out was very close apparently to our headquarters in the US or so I read it. Any ideas? I thought Pfizer may be close. Whoever it is was participating in the development of Vascepa at one time.
Disclaimer: I can give both arguments currently for getting NCE and being denied. I am leaning toward a thumbs up due to the delays and Dr. Goldenbergs argument. I agree that there is a patent issue as Williams has stated for us getting a ruling but it appears that to even to get an NME we need the patents with a 5052b. Something with patents IMO is holding up the decision whatever it may be. Good luck and thanks to those who have helped me learn along the way.
Thanks as always Kay.
I'm hoping that there is purpose with this being downloaded onto the website today. Here's hoping Williams is right:-), I'm sure pulling that he is. Lot's to read. It is interesting that they are certainly not applying as a enantiomer from a racemic mixture approach. They are going with the NO we do not have any active moiety or in a mixture of any active moiety approach. At least in several of the paperwork. In one of the latter they leave this question blank with something along the lines that they are waiting for NCE decision before filling in the blanks. Interesting stuff when you can peak behind the curtain on some of these companies. Keep up the awesome DD.
It was a good read wasn't it.
Complete and factual.
You can disagree with Steve if you want but at least he has laid out his argument clearly. I particularly enjoyed the interview with the sell side analyst from Aegis Capital.
We will know more in May but I anticipate FDA accepting our sNDA. I tend to be a little more pesimistic that it will be closer to EOY before we hear from them. Are sNDA's generally shorter than 10 month review?
My price target is a little lower than Steve's but I agree that everyone is overlooking Anchor. There may be time to get in the game down the road but I'm not taking that chance. I added a little last week and may add some more if NCE is denied.
Short sqeeze is inevitable and will probably sell portions of my shares into major catalyst events in the next 10 months.
I haven't read it yet but just found it. Enjoy.
replace with i,o,l
Lovaza is approved for triglycerides over 500. No malpractice there.
There is the issue though of a doctor wanting to do what is best for the patient however.
Please realize that with some people, if Lovaza is working well and trigs are markedly improved and no side effects noted in he 5 years on the meds, the doctor may review the advantages to Vascepa but not push for the change.
As soon as the doctor pushes too hard to a patient who likes the meds they are on, it never fails. The patient will pick up the stomach flu or get a migraine or something else completely not related to the switch to Vascepa and blame it on the new product. Just saying. Ask any doctor and they will tell you their war stories.