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ACC endorsement for Vascepa. (from Yahoo board)
https://www.investorvillage.com/smbd.asp?mb=2294&mn=5215&pt=msg&mid=19911467
Ringing endorsement and call for @US_FDA
approval of Vascepa from Dr John Nelson, Dir of CCI and former Board of Dir at NLA regulations.gov/document?D=...
(from @greenday_bio)
We moved on to other issues in our interview with Mr. Thero. About potential buyouts, partnering and so on, Mr. Thero was more cryptic, like I expected. I would have been surprised if he had told me which companies have sent out feelers, what prices were discussed, and so on. He did tell me that although he cannot get into specifics, “management is working to create shareholder value.” I think it means they are hearing from big pharma, but they won’t be easily sold. They don’t need to, after REDUCE-IT.
From Yahoo board:
Read this by Dr Nelson, one of the doctors working with Dr Budoff on the Evaporate Trial! Sounds like exciting news to me. For those saying it will be negative news, I think you are in for a rude awakening.
https://www.linkedin.com/pulse/i-am-thrilled-announce-drmatthew-budoff-presenting-john?trk=related_artice_%20I%20am%20Thrilled%20to%20Announce%20Dr.Matthew%20Budoff%20will%20be%20Presenting%20the%20EVAPORATE%20Study%20at%20the%20AHA%20Scientific%20Sessions-Late%20Breaking%20Science%20V1%3ANew%20Fronti_article-card_title
Jardiance has worse side effects
Fact: last time Sam did not post---scripts were down. Coincidence that he did not post today--I hope so.
I am not talking about August--rather the most recent tine Sam mdid not post. I am sorry you cannot follow my simple point.
Check the records Rafa and you will see that the sripts were down last time Sam did not post. And your comment of "nice try" is unfortunate b/c I am very long here.
last time when Sam did not post scripts--it was bad news.
lets hope today is different!
adcom comments mostly focus on requesting approval regardless of triglyceride levels. See below example of comment.
The greatest outcome from today's ICR report is that ICR makes the same argument!!!!
Example of comment:
I think all my at risk patients on statins would benefit regardless of the triglyceride levels as it appears the triglyceride level did no change the outcomes in the Reduce -It trial and likely the mechanism of action has nothing to do with lowering triglycerides and that is just a surrogate marker for inflammation reduction. I would like to see a broad label not including triglyceride to make insurance coverage simple for this inexpensive and effective drug
the pr will only highlight what ICR SAID NOT Amrn.
I think it will put pressure on fda not to go against the entire world.
Anyway I don't think IR will listen.
Great ICR--more important than B+ (or A-) they declared:
1) DFA NOT likely to require additional trial---they wouldn't say unless they know for a fact; and
2) . Specifically stating that the 135 levels are not important!
I will email IR to ask them to highlight this in PR.
ICR---recommending even levels less than 135!!!
" there is no strong reason to believe that icosapent ethyl is more effective at reducing CV risk for patients with triglyceride levels meeting the entry criteria for the trial.".....if the FDA label does not include a triglyceride level requirement, then plans may choose also not to have a criterion related to triglyceride level."
"the FDA is unlikely to require a second confirmatory clinical trial for this indication. "
from the ICR---good news
GS estimate is self-contradictory. They estimate only sales for 2020 at about $500 million, yet they write that their survey of physicians show a high level of awareness and willingness of dr's to prescribe vascepa.
how can enrollment be than a serious risk to initial roll out of vescepa?
Danouse, y u bother asking Rafa if he bought--its FAKE NEWS and if it is real than he and all his pals on tis board is guilty of inside trading.
When I got public info from Dr. Budogg (that even terra oharma was wrong about) I shared it with everyone--Rafa's nonesense is a joke.
VuBru, wish I could mute you--pathetic confirmation is useless--the info is not material anyway.
Mocha, you're encouraging Rafa's childish behavior.... I know something you don’t and I am bragging about it and I will only share with the cool posters
just b/c rafa contributes DOES NOT MEAN canplay the "I know something but cannot say game".
what exactly does the posters contribution help here? it does nothing to the sp.
I at least brought info from Dr. Budoff that was NOT KNOW--but I don't play games...
Rafa, why not post news if not inside info? so many posters say the same thing....I have info but can't say. It is getting old...
you are sound so silly. If rafa won't reveal the info there is no reason to believe him
Don't be worried about Adam F. regarding the label being higher than 135 (or mo issue), b/c AHA, NLA, and Europe all recommended 135 guideline! and fda won't go against everyone
Entire JT interview (that I received from ST poster)
Executive Summary
"We're planning for success," John Thero told Scrip in an interview, where he talked about the upcoming US advisory committee meeting for Vascepa, commercial expansion plans and deflected questions about a big pharma buyout.
As a single-product company with a potential cardiovascular blockbuster on its hands, Amarin has been considered a potential takeout target by a big pharma. But a huge $460m financing raise in July, which will be used to build out a big commercial structure, has raised some questions about whether a buyout will materialize.
The company's current cash balance stands at more than $600m, a dramatic change from previous years.
"I can't speak for big pharma. What we can focus in on is creating value, and we think we are doing that with our execution," Thero said of a potential acquisition. "Any company that grows, and grows considerably, is often in the spotlight."
He also pointed to the commercial opportunity for Vascepa outside the US and opportunities to build out the company's portfolio through a commercialization agreement. Amarin is frequently approached for co-promotion opportunities he said.
"There is no greater opportunity that I'm aware of right now that we could be working on than being successful with Vascepa, and we've got to get that right," he added.
To that end, the company is building out its sales force from 135 reps to 800, which it hopes to be fully operational in time for the launch at the end of December.
With 135 reps, Amarin was calling on about 20,000 physicians, but with 800 reps the target physician group will jump to 70,000 to 80,000. Those physicians write about half of all statin prescriptions, the company said.
There will also be a big direct-to-consumer marketing initiative, including advertising which will be phased in after the approval.
But for now, there's a lot riding on a successful showing before the review panel in November.
On The Issue Of Mineral Oil As Placebo
Amarin is anticipating the FDA ad comm topics for discussion will be broad, ranging from the unmet medical need to the REDUCE-IT trial design, and the efficacy and safety of Vascepa. As for one potential issue some investors have flagged – the use of mineral oil as placebo and corresponding increases in LDL-C in some of those patients – Thero downplayed the issue as a red flag.
"FDA helped us pick the placebo for this," he said. "I think anytime you have a result that is first of a kind, people end up asking questions about it and they for how do we explain this result, and I think most people that have looked have realized that the multi-factorial effect of Vascepa that goes well beyond a triglyceride reduction is the explanation."
The one worry in the back of his mind, he said, is the unknown. "I get paid to worry," he said. "I'm going into it thinking about this as an opportunity."
The rest of JT interview:
As a single-product company with a potential cardiovascular blockbuster on its hands, Amarin has been considered a potential takeout target by a big pharma. But a huge $460m financing raise in July, which will be used to build out a big commercial structure, has raised some questions about whether a buyout will materialize.
The company's current cash balance stands at more than $600m, a dramatic change from previous years.
"I can't speak for big pharma. What we can focus in on is creating value, and we think we are doing that with our execution," Thero said of a potential acquisition. "Any company that grows, and grows considerably, is often in the spotlight."
To that end, the company is building out its sales force from 135 reps to 800, which it hopes to be fully operational in time for the launch at the end of December.
With 135 reps, Amarin was calling on about 20,000 physicians, but with 800 reps the target physician group will jump to 70,000 to 80,000. Those physicians write about half of all statin prescriptions, the company said.
There will also be a big direct-to-consumer marketing initiative, including advertising which will be phased in after the approval.
But for now, there's a lot riding on a successful showing before the review panel in November
On The Issue Of Mineral Oil As Placebo
Amarin is anticipating the FDA ad comm topics for discussion will be broad, ranging from the unmet medical need to the REDUCE-IT trial design, and the efficacy and safety of Vascepa. As for one potential issue some investors have flagged – the use of mineral oil as placebo and corresponding increases in LDL-C in some of those patients – Thero downplayed the issue as a red flag.
"FDA helped us pick the placebo for this," he said. "I think anytime you have a result that is first of a kind, people end up asking questions about it and they for how do we explain this result, and I think most people that have looked have realized that the multi-factorial effect of Vascepa that goes well beyond a triglyceride reduction is the explanation."
The one worry in the back of his mind, he said, is the unknown. "I get paid to worry," he said. "I'm going into it thinking about this as an opportunity."
sometimes its better to go for doubles than a home run
Thank you Lawleycpa for the copy of Thero's interview (below)
Q: Why couldn't Thero have said this at the Thursday conference call!!! instead of reading the silly slides.
He also pointed to the commercial opportunity for Vascepa outside the US and opportunities to build out the company's portfolio through a commercialization agreement. Amarin is frequently approached for co-promotion opportunities he said.
"There is no greater opportunity that I'm aware of right now that we could be working on than being successful with Vascepa, and we've got to get that right," he added.
FYI----many doctors observed Jewish New Year this week (Mon-Tues) so numbers could be affected.
Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm:
Executive Summary
"We're planning for success," John Thero told Scrip in an interview, where he talked about the upcoming US advisory committee meeting for Vascepa, commercial expansion plans and deflected questions about a big pharma buyout.
***anyone have business email to register to "scrip" and get the rest of the interview?
here is the link: https://scrip.pharmaintelligence.informa.com/SC125969/Amarin-CEO-Thero-On-Gearing-Up-For-Success-Ahead-Of-The-Big-Vascepa-Ad-Comm
If you are correct---why not halt the Evaporate trial and show the world that there is no need for more data?
Dr. Budoff's explanation how interim results can be released: (my email is underneath with my question to him--for those who wonder why his replies to me--take notice that I sgive him a lot respect in my email))
"You can present interim results while a study is ongoing. That is literally the definition of the word interim."
Matthew Budoff MD
Professor of Medicine, UCLA
Endowed Chair of Preventive Cardiology
Los Angeles Biomedical Research Institute
1124 W Carson St
Torrance, CA 90502
F – 310 782-9652
From: Avi Silberberg
Sent: Wednesday, September 25, 2019 8:30 AM
To: Budoff, Matt <mbudoff@lundquist.org>
Subject: Re: duration of trial 9 or 18 months
[External Email]
Dear Dr. Budoff,
Thank you very much for your response.
Can you please just explain one last point, how can interim results be released while the trial continues as a blind study for 18 months?
Is the trial going to be an open trial after the AHA conference?
Again thank you for your time and dedication.
I wish more doctors had your unique qualities.
Have a good Rosh Hashana (if that is your observance),
Thank you,
Avi
Hi bidmark,
Yes he uses few words unfortunately.
Hi raf,
Thank you for welcoming me here.
I first emailed 2 days ago asking him whether he is presenting interim results and whether the Evaporate trial was ended.
He responded:
Trial is ongoing and we are presenting interim results.
Then I asked him yesterday to clarify if ongoing means 9 or 18 months (since some posters suggested that ongoing could refer to just 9 months----which would be nice since the trial is ending (and efficacy is assured).
Last night he responded:
The trial is ongoing to 18 months
All the best
Eight
All:
Dr. Budoff clarified further to me and confirmed the trial is ongoing for "18 months".
I wish he would have said 9 months to prove the results were positive, but like many opined it could be they want more data....
If you have any further follow up questions to ask him let me know and I might email him back.
Here is his email with a caption for all those who do not believe me:
"The trial is ongoing to 18 months"
Matthew Budoff MD
Professor of Medicine, UCLA
Endowed Chair of Preventive Cardiology
Los Angeles Biomedical Research Institute
1124 W Carson St
Torrance, CA 90502
P - 310 222-4107
F – 310 782-9652
Here is the email caption: I redacted my email.
from: Budoff, Matt <mbudoff@lundquist.org>
to: Avi Silberberg
date: Sep 24, 2019, 7:20 PM
subject: RE: duration of trial 9 or 18 months
mailed-by: lundquist.org
security: Standard encryption (TLS) Learn more
: Important mainly because it was sent directly to you.