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.
yes. I can't get it to post.
I am so sorry guys.
I was thinking the same thing. It may be a benefit for AMRN that this panel only has these two cases today.
I find it encouraging that Linn, Post and Dyk have already been on two panels this week Stoll and Reyna have been on one.
Are you guys really having this discussion. Look at the pictures people. There is less plaque in the arteries of those taking V.
lol - Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia
Stocks mentioned: ACST
Share
Listen
Save
LAVAL, Québec, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.
The Company reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks (the Primary Endpoint), as compared to 27.5% in TRILOGY 1. The unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a “p” value of 0.19, which was not statistically significant, and therefore the TRILOGY 2 study did not meet its primary endpoint. As a result, the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
CaPre was well tolerated in TRILOGY 2, with a safety profile similar to placebo, and consistent with the Company’s previously conducted Phase 2 and 3 studies.
“Compared to their baseline levels, the observed triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies,” said Dr. Dariush Mozaffarian, Professor at Tufts University and academic PI of the trial. “However, an unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved. We plan to now pool together the results from the two studies to see if we can better understand this phenomenon in post-hoc explorations. We want to thank all of the investigators for their participation, and Acasti for sponsoring the Trilogy program.”
Jan D’Alvise, Chief Executive Officer of Acasti, stated, “We are very disappointed in the outcome of the Trilogy 2 study. Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same “Pre-Randomization Triglyceride Normalization” effect that we saw in TRILOGY 1. While the triglyceride reduction observed in the control arm was less than what was observed in the Trilogy 1 Study, it still remains one of the highest seen amongst the previously conducted triglyceride reduction studies, and may be explained by the excellent background standard of care that is being provided to these patients today.”
D’Alvise continued, “We extend our sincere gratitude to all of the patients and their families, as well as the investigators who participated in this important trial, and to our employees who have worked tirelessly to develop and evaluate CaPre as a therapeutic for this indication. We especially want to thank Dr. Dariush Mozaffarian, our Principal Investigator, for his expert counsel and support throughout this program. The Acasti team and our clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2. Taking into consideration all of the analyses from TRILOGY once completed, we will seek to maximize the value of the CaPre® asset by continuing to explore a range of options available to us.”
The Company has decided not to host a conference call today as previously disclosed, as there is no additional material information at this time that can be shared beyond what is contained in this press release. The Company and its board of directors has been and will continue to evaluate all strategic options and will provide updates on this process as warranted.
Forward Looking Statements
Statements in this press release that are not statements of historical or current fact constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of U.S. federal securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti’s strategy, future operations, its review of strategic options, potential value for CaPre®, prospects and the plans of management.
The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the “Special Note Regarding Forward-Looking Statements” section contained in Acasti’s latest annual report on Form 10-K, which will be available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti’s website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti’s public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti’s latest annual report on Form 10-K under the caption “Risk Factors”.
Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
State of Judges from Yee -
The Tamiflu Fighters
@TamifluFighters
·
46m
From Jefferies (Yee): favorability of potential slate of judges for $AMRN appeal
From Jefferies (Yee): favorability of potential slate of judges for $AMRN appeal pic.twitter.com/FdxCYeZOrS
— The Tamiflu Fighters (@TamifluFighters) August 27, 2020
If AMRN does not have to use coupon to reduce the copay, this is good news for AMRN and their shareholders as Net Revenue per script will increase. Also, with the lower out of pocket for Vascepa, there is less advantage for a generic to be in the market.
This is not just any list. This is their Preventive Medications list. Your insurance benefit is applied before you meet your deductible each year. You know how we normally see a drop off at the beginning of the year. Not going to happen for United Healthcare patients.
HLS Therapeutics Supports Trial to Investigate the Effects of Vascepa® (Icosapent Ethyl) against COVID-19
https://markets.businessinsider.com/news/stocks/hls-therapeutics-supports-trial-to-investigate-the-effects-of-vascepa-icosapent-ethyl-against-covid-19-1029224987
GILD never said they would to profit from it. GILD said they would not profit from initial supply.
Yes, it is unbelievable, just like many of the things you post.
JPMorgan had the chance to catch up with $AMRN mgmt and wanted to share a
few points of feedback from our call. ..
? Insights into generic manufacturing capacity? Mgmt noted that there
are not that many companies who do omega-3 manufacturing and it is
not clear to AMRN who the generics are using for their supply. With the
ANDAs sitting with the FDA for some time now, we wonder whether
manufacturing could factor in to the lack of approvals thus far.
? Thoughts on appeal/path forward? Not surprisingly, Amarin intends
to appeal. Obviously whether any of the generics would launch at-risk
(once approved) while waiting for an appellate decision remains to be
seen. In the meantime, mgmt will continue to execute on their plan to
grow the market although they may not spend as much on DTC prior to
clarity on the appeal as they view this as a long-term investment.
Whether AMRN wins or loses on appeal, mgmt expects to ultimately be
able to run the company profitably and sees potential competitive
advantages in its manufacturing scale.
? What about Europe? Mgmt reiterated that this ruling does not change
things for Europe and they see potential for pricing in Europe that is at
least the same if not better than in the US since the price will be set on
the basis of the outcomes data. The company recently kicked off an EU
partnering process and will see what proposals come from that or
whether it makes more sense to go it alone in Europe.
These are unusual times. It is called expanded access. Drugs are shipped to the hospital at the hospital level and the hospital tracks patient progress on the sickest patients. Hopefully approval will come soon.
An Open Letter from our Chairman and CEO
Gilead Sciences
@GileadSciences
·
2h
Gilead has been working at unprecedented speed to enroll patients in clinical trials of our investigational treatment for COVID-19. Multiple studies are ongoing & we are on track to have initial data in the coming weeks. Read more from our Chairman & CEO: https://bit.ly/2wC3yD8.
https://www.gilead.com/stories/articles/an-open-letter-from-our-chairman-and-ceo
It's hard to say where the epicenter is without consistent testing.
Desantis has over 4,000 and they are no test available. They line people up in drive thru lines and tell people since they haven't traveled they can't be tested or they run out of test swabs. If they do get a test they are waiting 7 or 8 days for results.
They are trying to keep people from dying.
$GILD New expanded access clinical trial just posted today. https://clinicaltrials.gov/ct2/show/NCT04323761
Total scripts are where the revenue is at. That is all that matters.
Amarin may be the only company in 2020 that doesn't have to lower their guidance.
You should watch their twitter feed.
Wow Vascepa cures diabetes now. That is a new one.
Gilead's drug remdesivir has multiple clinical trials going around the country. Check with his physician to see if it is available and whether he may be a candidate.
I know they are shipping it directly to other hospitals. Outside of the clinical trials, they have moved from compassionate use on an individual basis to doing it at the hospital level.
Gilead's drug is moving from compassionate use to expanded use.
To those with access to Bloomberg terminal - I think there is a way to get total scripts across all prescriptions. It would be interesting to know what those numbers (percentage change) look like for the week.
Thank you Tucaman for the V. numbers.
Gilead has stated they are ramping up production.
Spring Break and all the people who flooded to Florida is going to be a major story. Anyone here in Florida right now should probably be quarantined when they head back north but we all know that is not going to happen. Our youth think they are invincible and they are going to kill many. The worst cases in Florida is exploding in Miami/Dade, Broward and Duvall Counties. Spring breakers will leave and the old people left behind in those counties are going to die.
Gilead is giving out the drug for compassionate use. There have been multiple reports the last couple of weeks of patients who were on death's door (hence the compassionate use) who have recovered. Information is all around you if you look for it. There was the WSJ article on the NIH physician last week that was basically ignored. CNBC has been too busy pumping other stocks to report about GILD.
I think they are using Gilead's drug under compassionate use criteria. It seems to be working but they can only give it to the very sickest right now. More info should be coming out soon. Piper just put out a note today on it, that they think FDA will approve quickly.
If you are bored, please fill out your census. I just did. You do not want those government employees having to knock at your door if you can help it. That will likely be a brutal job in this environment.
They are severely limiting the test here. All cases are travel related because they are not allowing testing unless you have traveled. It is going to be a cluster when all the north east spring breakers head for Florida.
So how many deaths did they not tell us about?
I picked up my three bottles two days ago. I just broke the seal on all three bottles and I do not smell fish.
Mine have come 100% from Walgreens. I think they are all encapsulated at the same place. It could be we have different senses of smell.
I have been on Vascepa since the beginning with one short break when my physician quit practicing. I have never had a fish burp. I had one bottle several years ago that smelled a little like fish. The pharmacy swapped it out for me after consulting with Amarin.
If he was being paid, he was being paid by the analyst.
Just to take the other side of it, We are also coming into a period of time where if you have cardiovascular disease and or diabetes you should not be skimping on your medications. Go get your refills now.
Glad the annual sales meeting for $AMRN already occurred and everyone got home safely.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwiLot2vvoToAhXCmeAKHUc9CggQxfQBMAB6BAgEEAM&url=https%3A%2F%2Fwww.nbcboston.com%2Fnews%2Flocal%2F3-who-attended-biogen-meeting-in-boston-test-positive-for-coronavirus%2F2086462%2F&usg=AOvVaw1g35TCwmRzDHvqg8JJFI7Q
I think that if someone filed an ANDA now they would need to contend with all of the Reduce-it patents. They are in the orange book.