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👋 @AFGENational & @AFLCIO,
— Raf 🍊 (@ra_fun) December 2, 2022
Why does @fepblue NOT cover VASCEPA to its 5.5 million members?
This drug reduces cardiovascular (CV) events by 25% & has a safety profile close to a placebo.
FEP-BLUE tried to substitute non CV drugs for this life saver.
Members deserve better👇 https://t.co/3FJIxhVQZ2
Please like and retweet -- 4 part thread.
👋 @US_FDA @FDACommissioner
— Raf 🍊 (@ra_fun) December 2, 2022
I would like to report a threat to public health & safety, perpetrated by @fepblue.
On p. 16-17 of their 2023 formulary, the following are listed as "CARDIOVASCULAR DRUGS".
But none of the highlighted have FDA-approved ...https://t.co/wy7nUSMd28
Pharmacists aren't sending their best.
After you finish virtue-signaling, can you please answer what happens to drug innovation when patents are being blatantly ignored?
— Raf 🍊 (@ra_fun) December 1, 2022
Why would any drug company risk billions 💸 and years 🕐 on R&D if the Generics can simply steal their innovation?
Do you really think that...
Don't sue me, Meo.
PS you'll have to stick with 1 because both cannot be true at the same time, bud. pic.twitter.com/6Y6JTA20yv
— Raf 🍊 (@ra_fun) December 1, 2022
I was way too polite.
Lots of 💩 in your tweet:
— Raf 🍊 (@ra_fun) December 1, 2022
1. Generic Icosapent Ethyl literally doesn't have a CVD label. Are you proposing that we ignore patents - what would that do for growth and invention of drugs?
2. Do you have any evidence that the Generic is "identical" to branded Vascepa because...
This is astonishing. Maybe the most impressive thing I've seen.
Is it relevant to Amarin? Probably not (yet) but it does mention inflammation and stroke. The clip starts at 17 minutes.
Very important point:
Too lazy to pull up the complaint, but what was HN accused of, preferential tier coverage for Generics, right?
Look what BCBS-FEP (my wife's & mine) and Emblem Health NY (my parents') are doing as of 2023 -- they're not covering Vascepa whatsoever and are coverage Generics in the lowest tier.
If Amarin could somehow use this settlement to change these practices, it would be a huge win.
Maybe this is why Amarin haven't launched the AG yet?
Must be the European sense of humor.
1/
— Tejas Desai, MD MBA (@nephondemand) November 30, 2022
30 Nov #FIFAWorldCup : France v Tunisia#FRA : Icosapent ethyl to reduce CV disease in CKD patients: https://t.co/PVk8PiFs78#TUN : Peritoneal dialysis experience: https://t.co/xFNziY5qGC
A great time to register is after #NRMPMatchDay: https://t.co/RmfrRWS9m6 pic.twitter.com/KZYTJj2weA
BREAKING! 2 weeks ago
Don't know how I missed this and apologies if this has been discussed, but 2 weeks ago, Amarin and Health Net have reached a settlement (in principal). We will know more by December 16.
This is very interesting that Amarin would settle,a after surviving motions to dismiss. Seems like they were in a good position to win, so it feels like they *should* only be settling in a way that sets a precedent for the industry at large (vs. one specific insurer...). Maybe getting an attractive agreement/concession lets them send out letters to every other insurer and threaten to sue them in same court if they don't effectively sign on too.
See the filing.
https://stocktwits.com/rafunrafun/message/498628805
Thoughts?
The only links that I have are my interactions with Dr Bhatt:
I am first waiting on some studies by my colleague Dr. Preston Mason to see if there are biological differences present or not between the formulations.
— Dr. Deepak L. Bhatt (@DLBHATTMD) January 27, 2022
He was never funded to do that experiment, and it would be expensive. It would involve long-term stability testing, for example, and that sort of work is usually done in commercial labs. Typically, companies with branded drugs do that on their own when generic drugs come out.
— Dr. Deepak L. Bhatt (@DLBHATTMD) November 6, 2022
I had assumed those would be worthwhile studies to do and be funded, but that did not happen. So, the only data (not anecdote) that exist are the data the FDA would have required and whatever internal data the company would have likely generated themselves (again, me assuming).
— Dr. Deepak L. Bhatt (@DLBHATTMD) November 6, 2022
OMG I'm salivating just from thinking what I would have done with such information.
Is Vascepa = Fake Vascepa?
I've asked IR multiple times if comparative tests of biological properties are/were conducted but they refuse to even acknowledge my question.
One would assume that a necessity of such tests is a no-brainer but I've learned not to make any assumptions with this management.
Per my interactions with Dr Bhatt, I actually think that no such tests have been conducted. If this is true, this is a bigger debacle than losing the patents because this is something that Amarin can control.
I urge everyone to email IR and ask them if comparative biological tests have been (or are being) conducted.
Vascepa TRx 63,877
Lovaza TRx 63,877
Scripts for week ending November 18, 2022
Drug Industry TRx: +0.5% w/w; +7.8% y/y
Vascepa
TRx 63,877; +1.2% (+728) w/w; -18.9% y/y
NRx 29,685; +3.2% (+919) w/w; -16.2% y/y
Ref 34,192; -0.6% (-191) w/w; -21.1% y/y
Fake Vascepa
TRx 42,446; +1.2% (+486) w/w; As % of total V: 39.9%
NRx 20,281; +2.2% (+431) w/w; As % of total V: 40.6%
Ref 22,165; +0.2% (+54) w/w; As % of total V: 39.3%
Fake Vascepa by Manufacturer
Hikma - TRx 15,107; +117 w/w; Generic share 35.6%; Total V share 14.2%
Reddy - TRx 19,245; +102 w/w; Generic share 45.3%; Total V share 18.1%
Apotex - TRx 7,890; +249 w/w; Generic share 18.6%; Total V share 7.4%
Teva - TRx 204; +17 w/w; Generic share 0.5%; Total V share 0.2%
Vascepa + Fake Vascepa
TRx 106,323; +1.2% (+1,214) w/w; +5.7% y/y
NRx 49,966; +2.8% (+1,351) w/w; +5.1% y/y
Ref 56,357; -0.2% (-137) w/w; +6.3% y/y
Lovaza (Fake & Brand)
TRx 63,877; +0.5% (+321) w/w; +0.6% y/y
NRx 31,008; -0.3% (-84) w/w; -0.3% y/y
Ref 32,868; +1.2% (+405) w/w; +1.6% y/y
Take a look -- scroll up.
2/X pic.twitter.com/hUgR3601jg
— Raf 🍊 (@ra_fun) November 26, 2022
My job isn't done yet.
http://stocktwits.com/rafunrafun/message/498110807
AHA aren't sending their best.
Never thought I'd see the day where AHA promotes peppermint candy canes, which are filled with SUGAR, which contributes to diabetes which causes CVD but are silent on the benefits of VASCEPA, which significantly reduces CVD!
— Raf 🍊 (@ra_fun) November 25, 2022
🚨VASCEPA > SUGAR🚨
Do better, AHA.@DLBHATTMD
The article has finally been retracted.
https://www.sciencedirect.com/science/article/pii/S2049080122016065?via%3Dihub
Chances of getting a real answer is close to 0%.
https://stocktwits.com/rafunrafun/message/498009224
Germany has been doing lots of losing while Japan has been doing lots of winning lately ... both with soccer & IPE.
JAPAN HAVE DONE IT! THEY’VE BEATEN THE GERMANS! 🤯
— Barstool Football (@StoolFootball) November 23, 2022
ANOTHER DAY. ANOTHER UPSET! 🇯🇵👏 pic.twitter.com/z6mTSNmub6
Maybe 24 more hours ...
https://stocktwits.com/rafunrafun/message/497558901
PS - Amarin has not contacted me - which I am ok with at this point.
PSS - I haven't seen the final final version, but I had a discussion with the authors regarding differentiating V from gV, where I pointed that only V has a CV label. I think there is a strong chance that such is added to the final version. If so, this may be the best article / manuscript written on IPE.
Take a look (4 parts).
https://stocktwits.com/rafunrafun/message/497432783
This is my last post here for today.
Capt & I have read the revised manuscript. IMO everything looks great, except the stroke part. I thought it wasn't wise to pick a fight over it with a risk of it not being published.
Yep, I received an explanation, a part of it is in the retraction letter. Not sure if I agree/believe or even fully understand it. But I don't want to concentrate on it (yet) or point fingers. I want to make sure that the new study gets published.
I'm learning as I go that to get things done in this sector, you can't solely go full throttle. It's a very careful mixture of that & finesse. AKA know when to bite your tongue.
I asked about Nissen's involvement and 1 of the 12 told me that he has never worked with Nissen.
Does this mean that Nissen didn't have any involvement with any of the 12? No it doesn't but this isn't my concern now. I just want to see the old paper get scrubbed and the new paper get published.
Moreover, if Nissen was involved originally and if the manuscript that was sent to me gets published, this would be the opposite of what Nissen would have wanted.
Do I think he was involved? I honestly don't know, 50/50 at best. But if he was, we'll probably never know. But I hope that he was because a (self) face palm hurts.
A retraction letter is below.
https://stocktwits.com/rafunrafun/message/497331128
For those without a StockTwits account, here is how I access it after I log out (may be different for others): after clicking the link, if I click on the body (text) of my post, it prompts me to log in. But if click on the letter itself, it opens the letter.
Update on the new study / article.
Amarin and I received a retraction/revision letter a new manuscript. The conclusion is:
FYI for full transparency: Amarin's IR & KM are fully aware as they just received the following email from the author.
Some of those cannot be copied and pasted (screenshots of screenshots of emails) but I don't think that a subscription is needed to access the links.
The most recent communication sent to me from the author this morning:
Bammmmm!
https://stocktwits.com/rafunrafun/message/497224488
It was sent after the below friendly reminder by me.
https://stocktwits.com/rafunrafun/message/497223364
BCBS are playing with fire. If you scroll up to page 32, you will see that Icosapent Ethyl falls under "cardiovascular agents". Should be slam dunk evidence if Amarin wanted to pursue in court for infringement.
I asked for a status update and this is what 1 of the 12 gave me:
Just spoke to one of the authors of the 'study' on the phone. An all-hands meeting (authors, publishers, etc) was just held.
I won't get into details of our conversation unless I am forced to (if the redaction is inadequate) but I'll tell you this much:
To say that they are apologetic is an understatement. A redaction and an apology are forthcoming.
Don't be surprised to see Bhatt's input as well.
This is my last post today. If anything new develops, I'll post on StockTwits.
Email sent: https://stocktwits.com/rafunrafun/message/497168954
PS - they clearly intentionally referred to Vascepa, not Lovaza. Go to the study and do a word search. Vascepa shows up 44 times, Lovaza 0. https://www.sciencedirect.com/science/article/pii/S2049080122016065?via%3Dihub
PSS - Received a first reply: https://stocktwits.com/rafunrafun/message/497169735
OMG he deleted that tweet and deleted his account after I replied!!!
I don't think I've ever seen anything more insane!!!
Like & retweet
🚨 @Amarincorp must sue @DryasarsattarMD & 🤡s who authored this 'study' into oblivion!
— Raf 🍊 (@ra_fun) November 19, 2022
This is straight fraud because none of these studies (ORIGIN, ASCEND & ALPHA OMEGA) used Vascepa!
Omega-3 mixtures ≠ Vascepa @DLBHATTMD @VietHeartPA@mmillermd1 @American_Heart @BudoffMd pic.twitter.com/AuhBPvoDq7
Scripts for week ending November 11, 2022
Drug Industry TRx: +0.1% w/w; +8.5% y/y
Vascepa
TRx 63,149; +1.1% (+711) w/w; -20.4% y/y
NRx 28,766; +0.5% (+150) w/w; -20.1% y/y
Ref 34,382; +1.7% (+561) w/w; -20.7% y/y
Fake Vascepa
TRx 41,961; +2.9% (+1,173) w/w; As % of total V: 39.9%
NRx 19,849; +3.0% (+579) w/w; As % of total V: 40.8%
Ref 22,111; +2.8% (+594) w/w; As % of total V: 39.1%
Fake Vascepa by Manufacturer
Hikma - TRx 14,990; +719 w/w; Generic share 35.7%; Total V share 14.3%
Reddy - TRx 19,143; +459 w/w; Generic share 45.6%; Total V share 18.2%
Apotex - TRx 7,641; +10 w/w; Generic share 18.2%; Total V share 7.3%
Teva - TRx 187; -13 w/w; Generic share 0.4%; Total V share 0.2%
Vascepa + Fake Vascepa
TRx 105,109; +1.8% (+1,884) w/w; +3.8% y/y
NRx 48,616; +1.5% (+729) w/w; +0.4% y/y
Ref 56,494; +2.1% (+1,155) w/w; +6.9% y/y
Lovaza (Fake & Brand)
TRx 63,556; +0.4% (+251) w/w; +1.4% y/y
NRx 31,092; +1.1% (+331) w/w; +0.9% y/y
Ref 32,464; -0.2% (-80) w/w; +1.8% y/y