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Please check FR0004163111 GNFT not GNFT on grey market.
Have fun navigating the $1 bid/ask spread on GNFTF.
I see all this promotion of Genfit whenever I see ICPT being discussed, and I am guessing that approximately NONE of you are actually long in GNFTF. The stock is unlisted and barely trades (volume under 2000 shares per day), and with its ridiculous spread, there's no guarantee that your money won't be held hostage.
Like the promise in Elafibranor, but not a viable investment until they uplist and get some legit volume support.
So can you all please just pipe down about it? Sheesh.
Elafibranor in Cover in Gastroenterology in May 2016
ac.els-cdn.com/S0016508516300075/1-s2.0-S0016508516300075-main.pdf?_tid =d1b2f434-07b3-11e6-8add-00000aacb362&acdnat=1461238138_d725e1709fa6ba447de9 e3bc101bfd2f
Look at this !
Click on the PDF link !
Is it not awesome ?
Elafibranor is really efficient against NASH
Major Actors are mainly ICPT and Genfit ...
But ICPT has already big problem to convince with PBC because of negative effects ...
Actually Genfit is in good place to be number one in NASH ...
Even FDA and authorities have asked to Genfit to go to PBC Market ...
"Elafibranor is expected to account for a major share of this market and the market for Elafibranor is expected to grow at the highest CAGR. This growth is majorly due to Elafibranor which is considered to be the most advanced drug in this category."
Nonalcoholic Steatohepatitis (NASH) Therapeutics Market to Reach US$20.27 bn by 2025, Elafibranor Projected to Spur Growth: Transparency Market Research
Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.
SOURCE Transparency Market Research
ALBANY, New York, April 18, 2016 /PRNewswire/ --
According to a new market report published by Transparency Market Research "Nonalcoholic Steatohepatitis Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 - 2025", the nonalcoholic steatohepatitis (NASH) therapeutics market is anticipated to expand at a CAGR of 10.7% from 2015 to 2025 to reach US$20.27 bn by 2025.
Download Research PDF: http://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=7691
Nonalcoholic Steatohepatitis (NASH) is a syndrome that advances in patients who are not alcoholic; it causes liver damage that is histologically indistinguishable from alcoholic hepatitis. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware of their liver problem. However, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and no longer able to work properly. It develops most frequently in patients with at least one of the following risk factors as obesity, dyslipidemia, and glucose intolerance. Pathogenesis is not clearly understood but seems to be linked to insulin resistance. Most of the patients are asymptomatic. Laboratory outcomes include elevations in aminotransferase levels. Biopsy is essential to confirm the diagnosis. Treatment mainly focusses on elimination of causes and risk factors.
Research Report with Toc & Free Analysis: http://www.transparencymarketresearch.com/nonalcoholic-steatohepatitis-market.html
The prevalence of NASH and NAFLD is increasing across the globe but it is more in developed regions such as North America. Both NASH and NAFLD are becoming more common, perhaps because of the greater number of Americans with obesity. In the past few years, the rate of obesity has almost doubled in adults and tripled in children. Obesity also adds to diabetes and high blood cholesterol, which can further complicate the health of people suffering from NASH. Diabetes and high blood cholesterol are also becoming more common among Americans.
Currently, no specific therapies exist for NASH treatment. The most important recommendations given to persons with this disease are weight reduction (if overweight), following a balanced and healthy diet, increasing physical activity, avoiding alcohol and avoiding unnecessary medications.
Request a Custom Report: http://www.transparencymarketresearch.com/sample/sample.php?flag=CR&rep_id=7691
The NASH market is segmented based on drug type which includes potential phase III candidates such as Obeticholic acid (OCA), Aramchol, Saroglitazar and Elafibranor. Moreover, the report enlists the candidates in Phase I and Phase II clinical trials. Based on the drug type, Elafibranor is expected to account for a major share of this market and the market for Elafibranor is expected to grow at the highest CAGR. This growth is majorly due to Elafibranor which is considered to be the most advanced drug in this category.
Major players in this market are Astazeneca Plc (U.K.), Intercept Pharmaceuticals Inc. (U.S.), Galmed Pharmaceuticals Ltd. (Israel), GENFIT SA (France), Gilead Sciences, Inc. (U.S.), Zydus Cadila (India), Immuron Ltd. (Australia), Conatus Pharmaceuticals (U.S.), and Tobira Therapeutics, Inc. (U.S.).
The Nonalcoholic Steatohepatitis (NASH) Therapeutics market has been segmented as follows:
Global Nonalcoholic Steatohepatitis (NASH) Therapeutics Market, By Drug Type
Overview
Potential Drug Candidates in Phase III
Obeticholic Acid (OCA)
Aramchol (arachidyl amido cholanoic acid)
Saroglitazar
Elafibranor
Weekly Biotech Report covering – Opko Health, Intercept Pharmaceuticals, Gilead Sciences, Inc Clovis Oncology
http://marketexclusive.com/weekly-biotech-report/5369/
Everyone expects FDA approval in PBC, so it's doubtful that there will be a significant pop when it happens.
When approval comes in May, all the shorting in the world won't save their asses.
You're probably right. Terrible system that the big guys developed and abuse us smaller citizens.
Correct. They're the bigger outfit so much weight is placed on them. The other 2 who claim $335 per share are much smaller.
I bet. MS has a large short position. Pure manipulation from a bunch of crooks
FALSE. Your comment was also wrong with respect to snake oil. FDA cleared the go ahead for APPROVAL!!!!!!!!!!!!!!!!!! To the moon for this stock!!
I might short on the news on Friday
Also heavy buying still in this range.
Looks like that's more likely then 80. But even the 200dma 172 seems like a no brainer.
*Could hit 200 but that would be a 52 week high
Well the chart looks bullish.
lol 300 maybe...someone knows it's going there from at least 2-3 months
Yes, but NO news after that until 2018.
Advisory Review Marks a Big Week for Intercept Pharmaceuticals
http://marketexclusive.com/advisory-review-marks-big-week-intercept-pharmaceuticals-inc-nasdaqicpt/5167/
Conclusion
The applicant’s model was informed by plasma concentrations of OCA and conjugates
observed in subjects with varying degrees of hepatic impairment (relatively rich model
development dataset) and was able to generally capture OCA exposure observed in subjects
with normal hepatic function and with hepatic impairment (verification datasets). The applicant
also predicted plasma and liver exposures of CDCA in subjects with normal hepatic function
and in subjects with severe hepatic impairment (cholestasis and non-cholestasis). Despite
several limitations recognized for modeling of both OCA and CDCA and the lack of
predictability of PBPK for hepatic impairment [13], the applicant’s prediction of liver OCA
exposures using PBPK is considered useful in supporting dosing recommendations of OCA in
patients with hepatic impairment.
Although the magnitude of elevation in liver OCA concentrations in subjects with severe
hepatic impairment was predicted to be less than that in plasma concentrations, there were
significantly higher plasma OCA exposures in subjects with moderate and severe hepatic
impairment compared to patients with normal liver function. With the evidence of doseresponse
relationship for pruritus (and related discontinuations, see main text of Question Based
Review) and unknown relationship of plasma/liver exposures to pruritus, a conservative
approach of adjustment of starting dose in subjects with severe hepatic impairment to match
plasma exposures to those subjects with normal hepatic function, followed by subsequent uptitrations
of dose and dosing frequency, appears reasonable.
Thanks for the document!
FDA briefing docs for PBC advisory committee:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM494108.pdf
I was thinking about selling the puts at that level. Do you think the announcement on Friday is going to be bad?
Buy Puts, $80 strike
There area ton of calls this morning on ICPT but 341 puts at $100 is a sign of someone betting for lower Friday open.
Market is pricing in a favorable FDA press release Thursday after the market close based upon company press releases to this point.,
Markets | Thu Mar 31, 2016 8:00am EDT Related: MARKETS, HEALTHCARE
Genfit plans to test its drug in second liver disease
French drugmaker Genfit SA on Thursday said it would begin a midstage trial this year of its experimental drug elafibranor to treat primary biliary cholangitis, a chronic disease in which bile ducts in the liver are gradually destroyed.
The company is already enrolling a 2,000-patient Phase III trial of elafibranor for the fast-growing fatty liver disease nonalcoholic steatohepatitis, or NASH, which is driven by obesity, diabetes and over-indulgent lifestyles and can lead to cirrhosis, liver failure and cancer.
Genfit expects the late-stage trial for NASH to be completed by mid-2018 with possible approval a year later in a market some analysts have said could grow to as much as $40 billion, with effective drugs racking up annual sales of $10 billion each.
"We think we can take 50 percent of the (NASH) market," Genfit Chief Executive Jean-Francois Mouney told Reuters.
Mouney said Genfit decided to also go after the far smaller primary biliary cholangitis (PBC) market because it believes its drug offers advantages over treatments from likely competitors, such as Intercept Pharmaceuticals Inc, and because most patients are not helped by current treatments.
The damage from PBC can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.
In earlier trials, the Genfit drug led to reductions in "bad" LDL cholesterol, triglycerides and blood sugar. Some potential rival drugs have caused LDL increases in clinical trials.
A panel of advisers to the U.S. Food and Drug Administration is scheduled next week to decide whether to recommend approval of Intercept's drug for PBC.
The Genfit PBC trial will test its one pill, once-a-day drug in patients who do not tolerate or do not respond sufficiently to the current standard treatment with ursodeoxycholic acid. That can be as many as 70 percent of PBC patients, Genfit said.
After discussions with experts in the field, we have decided "that PBC is the next logical target in our development plan," Mouney said in a statement.
The company made the announcement at a meeting in New York to discuss its research and development plans.
Genfit said it will work with regulatory agencies to determine the study goals and design in the coming months, with the aim of beginning the trial before the end of the year. (Reporting by Bill Berkrot; Editing by Bernard Orr)
Genfit will start Phase 2 for PBC this year
Genfit will need only 1 year to recruit 1000 patients for Phase 3 of Elafibranor
Per Market Exclusive: The FDA has set a PDUFA date for Intercept’s priority review, breakthrough designation lead development candidate, obeticholic acid in a primary biliary cirrhosis indication, of May 29, 2016, and an upcoming advisory panel meeting should offer insight into the likelihood of approval."
BIG FDA meeting on April 7th.
Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.
Does anyone know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.
Q. Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.
Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.
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