Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
BB- Please review attached document. It appears to me that program reviews only occur for BLAs and NDA applications, not sNDA applications. Thoughts?
https://www.fda.gov/media/99140/download
No one has mentioned that priority review was rescinded. The FDA obviously thinks there is a reason for a delay and until we get the FDA Federal Register notice of the Adcom we will not know what that is.
Insurance companies in the US are short sighted. They look at their out of pocket costs in the current year. The patient may not be their patient next year when that heart attack may happen. They do not always think long term and they are just slow to change.
Yes, some insurances commercial insurances are started to change their view of Vascepa. We need Vascepa to be the only drug available for the indication. The government regulated insurances, Medicaid and Medicare are slow to change and will need actual approval and a real indication to get this covered with reasonable copay. Generic lovaza scripts are still what they are because State Medicaid plans are not covering Vascepa, they are still going with the cheaper alternative. Right now there is still in inequity in the system. Those that can afford the drugs are getting them and those that can't are getting the unproven alternative.
Once we get approval, there will be no alternative. Insurances, whether commercial or government will need to cover the preventive drug with a reasonable copay. FDA approval will speed up the process of better coverage for everyone.
"Totally my speculation - I am a little concerned about insurance's willingness to provide good co-pay. As far as I know, all insurances have a short list of 10 or so drugs which cost them the most and closely monitor their usage. Lipitor used to be on that list. That suggests insurance tightly manages its drug cost. If they're not completely ethical (here comes my speculation), they may play the copay game to direct consumers/patients to cheaper, out-of-pocket DS. I hope this won't happen in the US. "
Currently Amarin provides a coupon which limits out of pocket costs for commercial insurance. I would imagine they will continue to do this until copays are lowered. Take a look at preventive drugs, look them up and how the U.S. Insurance industry handles them because of US laws. They have low copays because the government want patients taking their preventive drugs. Currently most patients get statins for $4 or $0 out of pocket costs. Insurance companies do not direct patients to DS, doctors would need to do that. Once FDA has approved Vascepa, Amarin will finalize access to Vascepa. No other drug will be available in this area, residual risk on top of statins so access will be there and Copays will be low. It will take time but it will happen. In the US, Insurance companies are not going to get away with saying, here take this unsubstantiated fish oil whose label may or may not be correct and whose drug may or may not be oxidized.
For proper insurance coverage, to get added to the preventive drug lists, to leave generic lovaza in the dust, we need FDA approval.
Please review attached document. It appears to me that program reviews only occur for BLAs and NDA's, not sNDA applications. Thoughts?
https://www.fda.gov/media/99140/download
So glad you are okay. This should be a good reminder for all of us that life is short and you should live it to the fullest.
"I mean Mary Parks (good find on your part I thought she was gone but the b*tch just changed her name)"
Post like this show someone's true colors.
It is not going to be a major issue because you are lowering the risk of heart attack and stroke which are more serious than afib. It will be on the label.
Even a layman should know you are not going to get a black box warning for a very small chance of afib.
Do you know why they don't sell this in Canada? They seem to sell a different formula, the label seems to have more DHA.
How do you know it is the best quality? Have you had it tested? How do you know it is not any better than anything else on the market?
Not unless he is just using this as a sign of confidence for his shareholders.
He held the shares so that should be a big positive for the stock.
The FR notice would not happen until later in the process. Only Amarin would receive the 55 workday initial notice of the meeting.
The False Promise of Fish Oil Supplements
https://blogs.scientificamerican.com/observations/the-false-promise-of-fish-oil-supplements/
This must be part of the all out blitz.
I think it would be fitting if Cletus has more followers than MRC. Sadly it isn't true right now. Can we make it happen?
This looks like it was a trial about late state heart failure not cardiovascular risk reduction.
Baker Brothers trimmed some off the top of their top six holdings, Amarin being one of them.
JL, you may have scooled him on this platform in the past but he is being left to run free on twitter. No one is schooling him there and it is a much bigger platform.
Information on icosapent ethyl crossing the blood brain barrier. https://www.drugbank.ca/drugs/DB08887
Here is a link to the funding by the NIH for the VA grant. It has different wording that may help. http://grantome.com/grant/NIH/I01-CX001261-04
Kiwi, if that happened the ADA has already spoken and so will the AHA and ACC. Physicians will still prescribe and insurances will still cover because it will be Standard of Care.
New (today) Dr. Bhatt article https://www.mdmag.com/medical-news/bhatt-subgroup-analyses-reduce-it-trial
Making the case for no trig level or at least 135.
He was caught off guard by the timing. His regulatory experts told him that it was no unlikely to occur. this late in the process.
Sorry to hear that. Condolences to you and your family. Please take care of yourself.
Cantor Fitzgerald note - Amarin panel not due to negative found by FDA, says Cantor Fitzgerald The panel meeting for Amarin's Vascepa is not being held because the FDA found something negative in its review, Cantor Fitzgerald analyst Louise Chen tells investors in a research note. Rather, the analyst thinks the FDA may be hosting an AdCom for Vascepa "because the drug will be used in a very large patient population." Further, Amarin has been preparing, and continues to prepare, for the panel, Chen contends. In addition, she cautions against reading the tea leaves on the FDA's assignment and cancellation of AdCom meetings based on some historical examples. The analyst reiterates an Overweight rating on Amarin with a $35 price target. Chen still thinks the peak sales potential of Vascepa is underappreciated at current share levels. The stock closed yesterday up 53c to $14.82.
Read more at:
https://thefly.com/landingPageNews.php?id=2951495
Of course it doesn't. Your wording was poor.
It is not right that people who are disabled or those who paid into Medicare all of their working lives can't get it. The FDA has created a system here where those who can pay out of pocket hav access to this but those who can't afford it can't get it.
I did post this over to twitter but MRC has never responded.
"Unfortunately, since AdComs only meet twice a year"
You are in over your head here. It may make more sense if you came here and asked questions instead of pretending to know what you are talking about. The board would probably be more receptive to that.
They have a whole website. There is nothing specific in the SEC regulations about FDA disclosures. As far as the SEC is concerned it is just material information that must be disclosed. Here is the 8-k that they sent to the FDA https://investor.amarincorp.com/static-files/e1fc2280-d34c-4b56-bd00-29648e025684 and here are some info on how to read an 8-k and what must be included. https://www.sec.gov/investor/pubs/readan8k.pdf
You are mixing up regulations. FDA vs SEC. He had to report it per SEC regulations. It was material to a small, one drug company. You can continue to listen to MRC if you want but you will lose all credibility here.
MRC blends facts with fiction in order to weave his case to fit his needs. I think too many have him on ignore and let him blow his smoke but that is all it is. You should be very careful with his "facts" and fact checking should be required no matter how fact based what he writes appears to be.
MRC tells us he has no expertise in any field. He has no background in law, patent law, SEC, FDA, Finance, stock market trading or anything else.
Wait, what information was submitted ?
Oh come on, why would anyone at the FDA listen to what Elizabeth Warren has to say with Mitch McConnell running the country.
INVESCO LTD increased their holdings by 7,854,902 as of 6/30.
THANK YOU! That is what I was not understanding from other's posts.
I would think is because of the retail fanatic ownership. IMO, we definitely got that.