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Aandeel Genfit PSE:GNFT.FR, FR0004163111

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Genfit 2018

82 Posts
Pagina: 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. [verwijderd] 3 januari 2018 23:53
    GENFIT TOP M&A CANDIDATE

    he AtonRâ Global Healthcare M&A certificate fell 1.3% in November, underperforming the MSCI World Health Care Index by 3.4%. Launch-to-date
    (September 15, 2017), it underperforms its reference index by 3.2%.
    November was uneventful in terms of M&A newsflow in Biotech, MedTech and Pharma. This is to change in the coming months as it is our strong belief that
    all the catalysts are in place and the best days are ahead of us. We are just missing the needed trigger, which might come from the US tax reform.
    As chances of a successful US tax reform have substantially increased in recent weeks, we believe that Pharma industry’s CEOs are just waiting to see what the
    final version of the bill looks like before getting their artillery out. If the tax reform bill is sent to Mr. Trump’s desk for signature before Christmas, and with
    some very high-profile conferences taking place in the next weeks (ASH in December and JP Morgan in January 2018 notably), the needed trigger would be in
    place for a completely different M&A environment heading into 2018.
    We also believe that one deal (notably a high-profile one) would ignite fire to the overall sector and that a re-rating process would immediately take place.
    This is the main reason why currently we are completely invested in the space.
    On a therapeutic-specific note, we had the chance to meet with the head of Research of Genfit (part of our portfolio), a French company focused on NASH
    (non-alcoholic steatohepatitis), which is a leading cause of liver disease in developed countries and a $35B+ market untapped opportunity.
    The company (top M&A candidate in our view) is still open to deals/collaborations but as they just recently successfully raised capital (through EUR180m
    convertibles offering), we feel the company would only accept offers if the premium is high enough. They see themselves as a perfect fit for Gilead Sciences,
    which is currently in Phase 2-b on NASH with GS4997.
    Genfit believes (as everyone else in the Street) that their closest competitor, Intercept Pharmaceuticals, has too many problems to solve with Ocaliva and that
    Genfit might be the first and only viable option. While we might agree with this statement, we also believe that the NASH epidemic (between 5% and 12% of
    US and European populations) cannot be solved by a one-pill/one-treatment alone but rather a combo therapy.
    While Intercept’s problems (toxicity, pruritus in 23% of patients as well as an increase in LDL levels) look insurmountable to many and Allergan’s (through the
    huge bet they made in 2016 with the acquisition of Tobira) latest Phase 2 results showed no significant difference in Fibrosis improvement between
    Cenicriviroc and Placebo at year two (positive effects of CVC on fibrosis seen at one year disappear at two years), we believe all the above-mentioned
    companies are hot M&A plays.
  5. [verwijderd] 14 januari 2018 09:02
    Intercept Vs. Genfit: Who Is Winning The NASH Race?

    SummaryGenfit and Intercept are leading the NASH race.Scientifically not much to choose between the two.We give a slight edge to Intercept because of Genfit’s decision to commercialize elafibroanor all

    “Since you're indicating in this recent articlethat you will write another piece of analysis shortly, we would like to draw your attention to a crucial element that you seem to have missed about our future commercialization strategy. Indeed, as mentioned consistently over ime and here (no link) again recently, GENFIT's intention with elafibranor is to generate a double source of income, retaining rights of elafibranor in some territories, but also reserving a significant share of the market for future partnerships. Would therefore be great if you could update your last article, considering that the current version provides quite misleading information to your readers. If you're interested, we can also propose a quick catch-up call before you write your next article, to make sure you have an updated picture on other key elements of our comprehensive program in liver and metabolic diseases which aims at addressing challenges in NASH and PBC treatment, NASH diagnosis, and NASH disease awareness.“

    After Gilead’s (GILD) Hepatitis-C franchise met with phenomenal success and equally phenomenal decline, focus shifted to a new area in the liver space - non-alcoholic steatohepatitis or NASH as it is more commonly known now. NASH is the next stage of non-alcoholic fatty liver disease or NAFLD and is characterized by liver damage and inflammation. NASH, if left untreated, eventually leads to advanced fibrosis, cirrhosis of the liver and ultimately hepatocellular carcinoma or HCC. The diagram below gives the different stages of the disease.

    Interest in the NASH space increased after a 2014 report from Deutsche Bank noting that the treatment market could be eventually worth more than $30 billion. That is from 0 to more than $30 billion in probably a decade. NASH was previously ignored by big biopharma as well as biotech companies. The reason was that up until a few years ago, NAFLD was seen as an effect of diabetes and therefore no treatment was developed for this disease.

    While it is true that obesity and type 2 diabetes do have a role to play in the advancement of the disease, recent researchhas shown that the disease can also occur in a significant proportion of NAFLD patients without diabetes. Recent research combined with the success of Gilead’s Hep C franchise and the Deutsche Bank report has therefore sparked significant interest in the NASH space.

    Not surprisingly, Gilead was initially seen as being a key player in the NASH space. However, what we have witnessed is intense competition and Gilead in fact is not even in the forefront. It must be noted here that Gilead has adopted a different strategy in the NASH space and is prepared to give up the chance to get to the market first. But this article is not focused on GILD’s NASH pipeline.

    It is focusing on the two companies that are unanimously seen as being at the forefront of the NASH treatment development. These companies are Intercept (ICPT) and French biotech Genfit (OTCPK:GNFTF). It has been a neck-and-neck race between the two companies, however, we believe that Intercept has the edge in the NASH treatment market as of now. And the edge is not based on the science.

    Intercept’s OCA vs. Genfit’s elafibranor

    Intercept is evaluating its obeticholic acid (OCA) in NASH. An agonist of farnesoid X receptor (‘FXR), OCA is already approved in the U.S. for the treatment of primary biliary cholangitis (‘PBC). OCA is marketed as Ocaliva in PBC. Since approval, Ocaliva has seen strong uptake despite some safety concerns.

    Genfit’s elafibranor on the other hand is an agonist of the peroxisome proliferator-activated receptors alpha and delta. Elafibranor has shown to improve insulin sensitivity, glucose homeostasis, and lipid metabolism.

    Both elafibranor and OCA are currently in Phase III development. And with the changes in the definition of NASH resolution (ballooning = 0; inflammation = 0-1; and steatosis = 0-3), we can now have an apple to apple comparison between the two during the Phase III trials, Genfit’s RESOLVE-IT and Intercept’s REGENERATE. The path to development has not been easy for two the companies. Given the vast number of NASH trials now in progress, enrollment has become a major issue.

    Both Intercept and Genfit (and in fact all Phase II and Phase III trials) have faced delays. The delay has pushed data readout to 2019 for both companies. Intercept in fact has gone and even reduced the number of patients it is enrolling for its Phase III trial. The patient reduction has allowed Intercept to cover some lost ground (a smart move in our opinion).

    Another smart thing ICPT has done is made changes to its endpoints. The earlier primary endpoint was fibrosis improvement and NASH resolution under new modified definition. The “and” has now been replaced with an “or,” which we believe lowers the bar somewhat. So after all the chopping and changing, here is how the two trials look like.

    Elafibranor

    Who has the edge?

    Scientifically there isn’t much to choose between elafibranor and OCA although Genfit bulls point to safety issues with OCA. The letter from ICPT last year to doctors regarding serious adverse events made their case stronger. But the serious adverse events were due to PBC patients being administered higher than recommended dose of OCA (something we discussed in an article on Seeking Alpha last year).

    We believe the market overreacted to the issue without looking at the details. In fact, the FDA has not issued a boxed warning or label change for OCA until now and we do not expect that to happen. This in-vitro study also highlights the fact that efficacy wise there is not a lot of difference between the two therapies.

    As of now, it is hard to say who has the edge in the NASH race. But if we had to stick our neck out, we would give an edge to Intercept. And the reason is Genfit’s decision to go all alone in commercializing elafibranor. At least that is the case as of now. The fact that Intercept already has an established liver franchise gives it a major edge in the NASH market. This is a huge market with a diverse set of prescribing physicians, and marketing outreach and sales can require big funding outlay. ICPT is stronger in that area.

    This is not to say that we are bearish on Genfit. But we do think Genfit has missed a trick by not finding a commercialization partner for elafibranor. In terms of valuation, both companies look quite attractive right now. Intercept has not recovered since the FDA letter regarding patient deaths with OCA.

    Genfit on the other hand has failed to take off despite getting some visibility in the U.S. In the end, if we had to make a recommendation, we would go for Genfit for investors with a higher risk appetite. If Genfit succeeds, the upside here could be more. Intercept on the other hand would be a safer bet for investors that are slightly risk averse.

    Disclosure: I am/we are long GILD.

    I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

  6. [verwijderd] 30 januari 2018 11:17
    The Science Behind Genfit's Elafibranor

    Elafibranor is an agonist of PPAR alpha and delta.

    PPARs belong to the nuclear receptor family, which have the potential to be effective in NASH treatment.

    Elafibranor also has a solid safety profile.

    In a recent note, we briefly discussed the two leading players in the NASH space: Genfit (OTCPK:GNFTF) and Intercept (ICPT). The note though did not dig deep into the science behind the two drug candidates, Genfit's elafibranor and Intercept's OCA. In this article, we will be focusing on the science behind elafibranor and look to find the reasons the drug candidate is seen as one of the most promising in the NASH space.

    Elafibranor in NASH
    Genfit's lead product candidate elafibranor is currently being evaluated in a phase 3 trial, RESOLVE-IT. The pivotal trial is evaluating the efficacy of elafibranor in subjects with NASH Activity Score of = 4. With F2 or F3 fibrosis. The trial's primary endpoint is NASH resolution under the new modified definition (ballooning = 0; inflammation = 0-1) without worsening of fibrosis.

    RESOLVE-IT is enrolling 2,000 patients (1,000 patients for an interim analysis) and data readout is expected in 2019 (interim analysis). This data, though, if positive, would support elafibranor's marketing application in both the U.S. and Europe. The trial will remain blinded after interim analysis and will continue post-marketing to confirm the long-term benefits of NASH resolution with elafibranor 120 mg dose.

    Science Behind Elafibranor
    Elafibranor is a dual peroxisome proliferator-activated receptor (PPAR) agonist. PPAR agonists have been found to be one of the most promising classes of anti-diabetic drugs. They have also shown to improve obesity-induced insulin resistance. There is a strong link between obesity and diabetes and non-alcoholic fatty liver disease (NAFLD), with the disease affecting 70-80% of individuals with obesity and diabetes (Chalasani, N. et al). This is the reason PPAR agonists hold so much promise in the treatment of NASH.

    PPAR agonists have shown to improve blood glucose levels and levels of blood lipids. PPARs belong to the nuclear receptor family and have three sub-types: PPAR-alpha, PPAR-gamma, and PPAR-delta or beta. Intercept's OCA is also a nuclear receptor. Elafibranor is an agonist of PPAR-alpha and PPAR-delta. PPAR-alpha plays a role in the breakdown and transport of fatty acids in the body. It also plays a role in reducing inflammation and this makes it interesting in the treatment of NASH. PPAR-delta, which is produced in cells throughout the body, plays a role in energy metabolism and reducing inflammation.

    seekingalpha.com/article/4140520-scie...
  7. [verwijderd] 31 januari 2018 11:34
    The NASH market is still under evaluated by the market.

    The fourth first drugs reaching the market could become blockbusters only because of the market size.

    The positive is that those biotech shares have come under a lot of pressure, reducing the risk/reward situation at these lower levels.

    An investment in only one candidate in NASH is highlyspeculative but if you bet on four or more candidates, you’ll reducedrastically your risk.

    seekingalpha.com/instablog/35674515-g...
  8. [verwijderd] 2 februari 2018 08:49
    Genfit 35% Low valuation, potential biggest profits

    Galectin 20% Low valuation, potential lucrative part of small market segment

    Galmed 10% Low valuation, bet on results

    Gilead 10% Three drug candidates on NASH

    Madrigal 10% High valuation, but encouraging potential

    Intercept 10% Low valuation, potential first drug on market

    Conatus 5% Low valuation, bet on results

    www.nashbiotechs.com/nash-biotech-ana...
  12. [verwijderd] 14 maart 2018 10:48
    GlobeNewswireMarch 13, 2018
    2017: a year of very significant reinforcement of the cash position (€274M at 12.31.2017), with all programs in the Company`s pipeline moving forward

    Financial results reflect in particular the signficiant ramp-up of the phase 3 RESOLVE-IT study of elafibranor in NASH and the €180M convertible bond issuance in Fall 2017


    Important progress in all of the Company`s other development programs and in particular those that are the most advanced: in vitro diagnostic and pediatric NASH; clinical development of elafibranor in PBC


    Results of the phase 2 study of elafibranor in PBC and filing of an IND application for the launch of a phase 2 study in fibrosis expected in 2018

    Lille (France), Cambridge (Massachusetts, United States), March 13, 2018 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical group at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces its annual financial results for 2017. A summary of the consolidated financial statements is included in this press release. The 2017 annual consolidated financial statements are available on the "Investors" page of the GENFIT website.
    Jean-François Mouney, Chairman & CEO of GENFIT, commented: "All programs in the pipeline, particularly those that are the most advanced, have moved forward or have reached significant milestones in 2017; whether it is the phase 3 clinical development program of elafibranor in NASH; phase 2 clinical development program evaluating elafibranor in PBC, which mid-year entered its active recruitment phase; or even our NASH in vitro diagnostic (IVD) program that successfully completed its feasibility phase and began its development phase last June.
  13. forum rang 10 DeZwarteRidder 5 april 2018 17:54
    Conatus Pharma shares fall on liver-drug study data

    Published: Apr 4, 2018 5:05 p.m. ET
    By Wallace Witkowski
    Reporter

    Conatus Pharmaceuticals Inc. CNAT, -31.78% shares dropped in the extended session after the biotech company said a clinical study of its liver disease treatment did not reach its goals. Conatus shares, which had been halted before the announcement, fell 27% after hours, following a 2.6% gain to close at $6.01 in the regular session. The company said its drug emricasan did not show a significantly better overall response rate compared with placebo in liver transplant patients with fibrosis or cirrhosis. Back in December 2016, shares had more than doubled after the company announced a licensing and collaboration deal with Novartis for emricasan.
  14. sp1946 7 april 2018 15:33
    Voor wat het waard is.

    Genfit - Integrated Strategy For The Management Of NASH Offers Upside Potential
    Apr. 5, 2018 12:51 PM ET
    |
    Kailyn Hui
    Biotech, healthcare
    Summary
    Elafibranor and BMGFT03 (NASH diagnostic biomarkers program) are the key revenue drivers.
    BMGFT03 IVD test for NASH screening and detection provides NASH market expansion potential and effectively maximizes the sales of Elafibranor.
    Elafibranor phase 3 intermediary results are expected in 3Q 2019. BMGFT03 is expected to be commercialized in 2020/2021.
    Editor's note: Seeking Alpha is proud to welcome Kailyn Hui as a new contributor. It's easy to become a Seeking Alpha contributor and earn money for your best investment ideas. Active contributors also get free access to the SA PRO archive. Click here to find out more »
    Genfit (OTCPK:GNFTF) is a biopharmaceutical company specializing in the discovery and development of therapeutic and diagnostic solutions in the area of metabolic, inflammatory, autoimmune and fibrotic diseases, in particular liver and gastrointestinal diseases. The company's pipeline includes Elafibranor (NASH, PBC), NASH diagnostic biomarkers program (BMGFT03), TGFTX4 program (anti-fibrotic) and TGFTX1 program (inflammatory and autoimmune diseases). The company was founded in 1999 with headquarters in Loos, France, and a U.S. subsidiary in Cambridge, Massachusetts.
    Investment Thesis
    I believe Elafibranor and BMGFT03 programs are the key drivers of revenue growth. The global NASH market is forecast to reach US$15-20 billion by 2025. Currently, opinions primarily focus on the therapeutic area when evaluating the company, whereas the NASH diagnostic biomarker has been overlooked; the global NASH biomarker market is forecast to reach US$2 billion by 2025 according to Grand View Research.
    Elafibranor has been granted fast track designation by the FDA. A phase 3 clinical trial for the treatment of NASH, RESOLVE-IT, has started to evaluate the beneficial effect and safety against placebo in NASH patients with F2 or F3 fibrosis. The phase 3 intermediary results are expected in 3Q 2019 and marketing authorization is planned in 2020.
    Elafibranor is also being evaluated in a phase 2B clinical trial for the pediatric NASH, and a phase 2 clinical trial for primary biliary cholangitis (PBC).
    NASH is a liver disease causing scarring and inflammation, leading to cirrhosis, liver failure, liver cancer, and increase the risk of cardiovascular problems.
    The total addressable market of NASH in the US is about 16 million cases in 2015, and it is projected to reach 27 million cases in 2030.
    The BMGFT03 program aims to develop a non-invasive and easy-to-access diagnostic blood test for the detection and management of NASH, as well as optimize the clinical outcomes by identifying patients who best respond to Elafibranor or any other suitable treatment.
    The total addressable market of the NASH IVD test is immense. It potentially includes NASH patients and patients at risk - overweight, obese, type 2 diabetes, prediabetes and NAFLD population. For instance, the NAFLD population in the US is about 83 million cases in 2015, and it is projected to reach 100 million cases by 2030.
    The BMGFT03 program has started the development phase in 2017 and is expected to be launched in 2020/2021.
    Catalyst Calendar
    Here I summarize the catalysts in a table below. The catalysts could create significant value through pipeline de-risking and commercialization.

    Valuation
    Following is my revenue projection:

    I assume the price of Elafibranor at €4,600 per course of treatment based on the price of Ocaliva, a treatment for PBC currently being evaluated in Phase 3 clinical trial for NASH, which costs US$5,700 per course. NASH IVD test is at 30% of the market penetration.
    Based on my projection, Elafibranor revenues will peak at ~€1.6 billion and the NASH IVD test will peak at ~€700 million in 2029E.
    Price Target US$125 (€101)
    The price target is derived from my discounted cash flows analysis that uses a WACC of 16.72% and 2% terminal growth. Revenue drivers in my model are Elafibranor for NASH patients with F2-F3 fibrosis and the NASH IVD test would launch in 2020E; the revenue projection is shown above. These assumptions produce the following unlevered free cash flow result and a price target at €101 per share. The model shows 300% upside potential with Genfit currently trading at €23.36.

    Bull US$205 (€166)
    In the bull case, I assume BMGFT03 IVD test for NASH screening and detection provides NASH market expansion potential and effectively maximizes the sales of Elafibranor with quick market adoption.
    Bear US$44 (€36)
    In the bear case, I assume Elafibranor fails in NASH. However, the diagnostic test performance would not be affected and launch in 2020E.

    (Source: Genfit)
    Conclusion
    I recommend buying Genfit which currently trades at US$29 per share. I believe Elafibranor and the NASH IVD test are the key revenue drivers which offer significantly more upside. I expect the share price to trend higher in a range of US$44-205.

  15. [verwijderd] 11 april 2018 10:13
    www.genfit.com/wp-content/uploads/201...

    GENFIT: Major Milestone for the RESOLVE-IT Phase 3 Trial on the
    Recruitment of the Interim Analysis Cohort
    - Recruitment of the patient cohort for accelerated approval has been
    reached
    - Interim baseline data on the first 1,000 randomized patients shows good
    distribution of patient recruitment worldwide
    Lille (France), Cambridge (Massachusetts, United States), April 11, 2018 –

    GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the
    forefront of developing therapeutic and diagnostic solutions in metabolic and
    inflammatory diseases, that notably affect the liver or the gastrointestinal system, today
    announced that the RESOLVE-IT trial in NASH and fibrosis has reached the target
    recruitment for the interim cohort analysis.
    GENFIT’s phase 3 registration trial RESOLVE-IT is an international study evaluating the
    efficacy and safety of elafibranor 120mg once daily in patients with NASH and fibrosis.
    The primary endpoint is the resolution of NASH without worsening of fibrosis after 72
    weeks of treatment.
    The recruitment of the patients needed for this analysis has been completed.
    The analysis of this histological endpoint will serve as the basis for accelerated approval
    under Subpart H in the US and international market approval. The phase 3 will continue
    to enroll the full cohort for long term clinical benefit analysis, based on progression to
    cirrhosis, mortality, and liver-related outcomes.
    The recruitment has also been achieved for the exploratory arm of patients with F1 stage
    fibrosis.
    As initially announced, focus has been made on the balanced distribution of treatments
    across all sites and countries, based on stratification according to gender, diabetes, and
    disease severity. In the international setting, patients have been enrolled in more than
    250 sites across North America, Europe, Australia, Latin America, Turkey and South
    Africa.
    Interim baseline data on the first 1,000 randomized patients show that these NASH
    patients have metabolic co-morbidities, with 48% having type 2 diabetes, 59% having
    hypertension, and 51% having dyslipidemia. The average BMI is 34. Hispanics represent
    25% of the study population. The baseline characteristics of the study population are in
    line with the expected associated risk factors for NASH and fibrosis.
  16. sp1946 11 april 2018 10:48
    Voor morgen:

    Poster presentations
    Thursday April 12, 2018

    - “Expression profiling of 728 miRNAs in a NASH model identifies excellent correlations of hepatic and circulating miR-34a levels with histological lesions in rats and men”, G. Cordonnier et al. (THU-482)
    - “Elafibranor and nitazoxanide synergize to reduce fibrosis in a NASH model”, R. Walczak et al. (THU-494)

    1 The 53rd Annual Meeting of the European Association for the Study of the Liver (EASL)
  17. sp1946 11 april 2018 10:52
    NASH! THE INTERIM COHORT RECRUITMENT NEEDED FOR CLINICAL TRIAL PHASE 3 IS REACHED FOR THE TWO LEADERS




    GENFIT ($GNFTF) announced today (Apr 11 2018) that recruitment of the patient cohort (1000 patients) for accelerated approval has been reached in RESOLV’IT. Intercept ($ICPT) announced in may 2017 that they had closed interim recruitment (750 patients) in REGENERATE.
    GENFIT provided details on this recruitment and that baseline data on the first 1,000 randomized patients shows good distribution of patient recruitment worldwide. As their Phase 2b was jeopardized because of a fast non-balanced recruitment, GENFIT decided to take its time on phase 3.
    They selected cohort regarding balanced distribution of treatments across all sites and countries, based on stratification according to gender, diabetes, and disease severity. In the international setting, patients have been enrolled in more than 250 sites across North America, Europe, Australia, Latin America, Turkey and South Africa.
    The purpose of this is clear, they bet on an accelerated FDA approval because of their representative cohort. They learned from the delayed agreement of OCA in PBC because of a non-representative panel of patients that was different from FDA expectations.
    We can hope that INTERCEPT also learned from that, because as they planned initially to recruit 1400 patients for interim results, they announced in march 2017 that they decided to reduce the cohort to 750 only and never transmitted data’s on their interim cohort profile.
    This choice seems mainly conducted by their decision to keep the lead on timing but will undoubtedly weak the future strength of REGENERATE trial.
    The number of patients recruited by arm for interim results will be 250 and one can bet that, at the end, because of potential aborts, results would be presented on less than 230 patients per arm.
    To compare, ELAFIBRANOR arm in interim results of RESOLV’IT will include 666 patients and, because of potential aborts, results would be presented on almost 600 patients.
    If the ELAFIBRANOR Cohort is very well balanced as GENFIT declared, the time lost in recruitment selection can be recovered in FDA analysis and accelerated agreement.
    It would be interesting for INTERCEPT to provide some data’s on their interim recruitment baselines to let analysts evaluate a possible misfit in future agreement delay from the FDA.

    G Divry
82 Posts
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