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Home  /  Forum  /  BioPharma  /  Heeft CytoDyn het ultieme anti-HIV-middel??

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Heeft CytoDyn het ultieme anti-HIV-middel??

1.071 Posts
Pagina: «« 1 ... 37 38 39 40 41 ... 54 »» | Laatste | Omlaag ↓
  1. forum rang 5 MisterBlues 2 september 2020 10:28
    quote:

    FatCool schreef op 1 september 2020 20:32:

    [...]

    Maar de politiek (VN/WHO/EU) wil zo graag vaccines, dat een goede behandelmethode gewoon niet in de plannen past. Daarmee geef ik Leronlimab op voor Covid. Als de FDA om een fase 3 vraagt, gewoon niet doen, zonde van de tijd en de kosten. Toestemming als de ziekte over is.

    fc
    Het niet uitvoeren van fase 3 zal Cydy veel kosten: het is immers Covid-19 dat het beursvuurtje heeft aangewakkerd en hooghoudt. De kosten worden sinds jaar en dag met succes verhaald op anderen waaronder de beleggers. In de tussentijd is het complete managementteam meervoudig miljonair geworden. Ze vragen nu ook met een nieuwe emissie meer geld. Zie Engelstalige tekst onderaan.

    Covid is overigens een blijvertje voor nog wel 2 jaar. De angel mag er een beetje uitgehaald worden, maar daarmee is de pandemie nog niet verdwenen / opgelost. (Laten we hier echter niet over discussiëren maar laat de tijd het ons leren.)

    Heel weinig bedrijven vanuit de OTC krijgen een uplisting voor elkaar. Die kans is heel klein. Dat wordt het zoveelste gebed zonder einde.

    Morgen krijgen we te horen dat de BLA ook nog niet goed zal zitten, of dat het allemaal de schuld is van de FDA.

    Dat de FDA zo corrupt is dat ze nu alleen vaccins zullen goedkeuren is een typische stelling die door Cydy-fans voor waar wordt versleten. Voorbeeld van hoe er gemanipuleerd wordt door Cydy management en aanhang: een stelling als een beschuldiging uiten zonder bewijzen en argumenten aan te leveren, zodat het niet meer op een stelling lijkt.

    Cydy vormt een team van wetenschappers die zich over de rug van dommige beleggers aan het verrijken zijn met een middel dat niet schadelijk is, maar waarvan de bewijzen duidelijk niet zo overweldigend zijn als wel wordt beweerd.

    1. NP is asking for 25% of the total shares we just approved for incentives. At this rate, we will be at 800M shares outstanding in a minute. I'm not saying I will not incentivize but not at 25M shares (or > $75) in one year for 20 employees. Unfortunately, I do not even know what I'm incentivizing at this point. NP had hinted earlier that if he had to dilute, it will be about 10M share and the price would have been above $7.50. The SP is $3.40. Let us revisit when we are above $7.50, but not 25M at this point.

    2. I can understand asking for shares after some sort of approval, EUA, or uplisting. None of that has happened. If. Any of that has happened, 25M share is still excessive. Assuming there is a covid19 approval, I could justify a "yes" vote because there is revenue. At this time, with the price at low $3s is not a good time to ask for 25M shares.

    3. If the stock price is up because of some approval, EUA or uploading, 25M shares will still be too much for one year. Mind you, he is also asking for an evergreen 1% of outstanding shares increase annually. That is unsustainable. We will need revenues to begin to understand the implication of this vote. That does not sound like minimal dilution.

    4. The only time 25M makes sense is if the SP tanks. That takes us back to bullet point #1 above: what are we incentivizing?

    I will vote "no" at this point and NP can come back later on after we have had some successes to request for incentives. Let us keep the salaries going for now until such time and let's keep the bulk of the 100M shares for RCTs

  2. forum rang 5 MisterBlues 2 september 2020 20:37
    About Uplisting

    Only 60 companies on average achieve an uplisting each year, representing just 0.0052% of the 10,000 stocks on the OTCQB. Of the companies that uplist, approximately 75% of them uplist to the NASDAQ.

    There are several important factors that go into determining if, and when, a company decides to uplist, primarily cost, ongoing listing requirements, timing, and adequate advisors. Perhaps most important, though, is a stomach of steel. Only those companies with the most meticulous of business plans and the most qualified of management and advisory teams should even attempt uplisting.
    There are 2 ways to be listed on an exchange like NASDAQ: IPO or Uplist
  3. forum rang 5 MisterBlues 3 september 2020 10:31
    Hopelijk worden er spijkers met koppen geslagen bij deze 2 besprekingen. Dat zou opluchting geven.

    U.K. MHRA Grants Meeting to CytoDyn to Discuss Fast Track Approval of Leronlimab for COVID-19 Patients

    September 02, 2020 4:01pm EDT

    U.S. FDA schedules Type A meeting with CytoDyn to discuss BLA filing for HIV

    VANCOUVER, Washington, Sept. 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government requested a meeting with CytoDyn on September 9, 2020 to discuss the Company’s request for Fast Track approval of leronlimab to treat COVID-19 patients with mild-to-moderate symptoms based upon the trial’s Top-line Report and additional eIND data. On the suggestion of the MHRA, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company’s CD12 trial an urgent health issue.

    In addition, the U.S. Food and Drug Administration (FDA) advised the Company the agency has scheduled a Type A meeting on September 8, 2020, following the Company’s receipt of the agency’s written responses on September 1 concerning it Biologic License Application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients. The FDA clarified the items it needed primarily related to dosage levels.

    Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very encouraged by the MHRA’s considering fast track approval of leronlimab and granting us a meeting. In this meeting, CytoDyn will present a summary of its BLA for HIV in conjunction with our request for fast track approval for COVID-19 indication. We are also grateful to the MHRA for advising us about potential financial support from the sites and UK government for our CD12 study currently in process. We also look forward to meeting with the FDA to help expedite the resubmission of our BLA, as well as learning whether we receive Emergency Use Approval for leronlimab for COVID-19 or, alternatively, are required to proceed with a Phase 3 trial. Regardless, we are working diligently to ensure the availability of leronlimab worldwide to provide a potential benefit for patients infected with this terrible disease.”

    About Coronavirus Disease 2019
    CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. and submitted the trial’s Top-line Report to the U.S. FDA for emergency use approval and to the U.K. MHRA to request Fast Track Approval. While enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S., an interim analysis on the first 195 patients will be performed in approximately four weeks with results anticipated in mid-October.
  4. forum rang 5 MisterBlues 4 september 2020 08:44
    The World of Leronlimab for all to see: Updated 9/3

    Potential Catalysts w/ Est. Dates 9-3-2020

    COVID CD10 Mild / Moderate

    - UK MHRA Delivery of Data Package – September 4
    - UK MHRA Pre-BLA Fast Track Meeting – September 9
    - UK MHRA Ruling – ?

    - US FDA EUA Ruling – “Forthcoming”

    - Mexico NIH Ruling – ?
    - EU EMA Submission – ?
    - Philippines FDA Submission – ?
    - Israel MOH Submission – ?

    * The US FDA may grant Phase 4 Confirmational or demand a Phase 3 Registrational

    COVID CD12 Severe / Critical

    - US FDA Interim 28-Day Completion – Sept 23
    - US FDA Interim Top-Line Results – First Half Oct
    - US FDA Interim EUA Submission – Oct
    - US FDA Interim EUA Ruling – ?

    - UK MHRA Interim EUA Submission – Oct
    - UK MHRA Interim EUA Ruling – ?

    * The US FDA may demand full Phase 3 enrollment (390)

    COVID Funding / Partnerships

    - UK MHRA UPH Urgent Public Health Submission – Sept/Oct

    - US OWS / Funding / Grants Update – Sept/Oct

    - Worldwide Pharma License/Partnership Update – Sept/Oct
    - Small Pharma License/Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – Sept/Oct

    COVID Manuscripts

    - Dr. Patterson Peer Reviewed Paper – Very Soon

    - CD10 Paper Dr. Seethamraju Review – Week of Sept 7
    - CD10 Paper Dr. Seethamraju Submit – ?

    - CD10 Abstract Results Submit – ?

    - Dr. Yang Paper - 29-Patients – Submitted
    - Dr. Yang Paper Publish – ?

    - Dr. Agresti Paper - 4-Patients – Submitted
    - Dr. Agresti Paper Publish – ?

    COVID Miscellaneous Items

    - Samsung Biologics Shipment Update – Sept/Oct
    - Mainstream Media Update – Sept/Oct
    - IncellDx Companion Assay Kits – Sept/Oct
    - Brazil ANVISA COVID Trial Update – ?

    HIV Indications

    - US FDA Combo HIV BLA Type A Meeting (w/Mono Guidance) – Sept 8
    - US FDA Combo HIV BLA Multidisciplinary Review – 30+ Days
    - US FDA Combo HIV BLA Re-Submission (w/Mono?) – ?
    - US FDA Combo HIV (w/Mono?) Ruling– ?

    - UK MHRA Combo & Mono Pre-BLA Meeting – By Sept 20
    - UK MHRA Combo & Mono BLA Submission – ?
    - UK MHRA Combo & Mono BLA Ruling – ?

    - US HIV Cure Trial Update – ?
    - US HIV PrEP OHSU/Sacha Animal Study Completion – Aug 2025

    HIV Manuscripts

    - HIV PrEP Animal Study Paper – Sept
    - CD01 Extension Paper – Sept
    - CD02 & CD03 Papers – ?

    Cancer Indications

    - US FDA Response to Basket 700mg Change – ?
    - US FDA BTD Cancer Meeting: mTNBC + Basket 22 – Sept
    - US mTNBC Trial Update – ?
    - US Cancer Basket 22 Trial Update – ?
    - Taiwan Cancer Basket Trial Update – ?

    Other Indications

    - MS Trial Update – ?
    - NASH Trial Update – 1st Patient Sept
    - GvHD Trial Update – ?
    - Alzheimer’s Trial Update – ?

    Corporate Items

    - Science Advisory Board Update PR – Sept
    - Investment Bank Update – Sept/Oct
    - NASDAQ Uplist Est. Date – Sept/Oct
    - Next Capital Raise Post Approval or Uplist – ?

    Potential Additional Trials for 2020:
    As reported from time-to-time by CYDY

    Phase 2:

    - Influenza
    - Stroke
    - Septic Shock
    - IBS Inflammatory Bowel Syndrome
    - Psoriasis
    - Autoimmune Hepatitis

    Phase 3:

    - US COVID PrEP
    - US COVID Long Hauler (Label Expansion?)
    - HIV Mono Therapy

    Completed Catalysts
    - Dr.BP Paper Pre-print
    - US COVID Pediatric Protocol
    - NEJM Submissions Amarex Montefiore / Georgia
    - US COVID Distribution Agreement
    - Dr. Sacha HIV PrEP Presentation
    - Small Capital Raise Before Uplist
    - US COVID P2 M/M Top Line Efficacy Results
    - US COVID P2 M/M FDA EUA Unmet Need Submission – Aug 12
    - SEC 10k & Audited Financials Complete – Aug 17
    - Mexico NIH P2 M/M Submission – Aug 17
    - UK MHRA P2 M/M “Fast Track” Submit – Aug 19
    - UK MHRA Enrollment
    - US FDA Interim Enrollment (195) – Aug 25

    Back-Burner Catalysts
    - Dr.BP Paper #2 Pre-Print
    - Dr.BP Paper #2 Peer Review
    - Dr.BP Infectious Virus in Plasma
    - Dr.BP Rantes Susceptibility Testing Program
    - Commercialization Officer Full-Time Hire

    Rejected Catalysts
    - US COVID Emergency eIND
    - US COVID Compassionate Use Pre-July
    - Mexico NIH COVID Combo Trial
    - US COVID P3 3-Arm trial w/Remdesivir
  6. [verwijderd] 5 september 2020 11:43
    Ik denk dat wij wel weten wat deze juffrouw heeft genezen. Maar ze staat hier reclame te maken voor bloedplasma, iets waar we in Nederland mee gestopt zijn (voor zover ik weet).

    fc

    Young Houston woman recovers from COVID-19 after participation in two UTHealth clinical trials

    September 04, 2020

    Heba Hajjar, 23, recovered from COVID-19 after participating in two clinical trials through The University of Texas Health Science Center at Houston (UTHealth) while in the intensive care unit (ICU) at Memorial Hermann-Texas Medical Center.

    She was so weak she couldn’t move or sit up in bed. She was cautiously monitored on oxygen therapy and was asked to sleep on her abdomen to keep her oxygen levels up. After a few days, she became critically ill and was on the verge of being placed on the ventilator. As part of ongoing COVID-19 research, she was given a convalescent plasma transfusion.

    “The day after receiving the plasma, I asked the nurse if I could try to sit upright in bed, something I hadn’t been able to do for the last several days,” Hajjar said. “So, we tried and I was able to do it, and not long after, I was able to stand up by myself.”

    Hajjar was discharged two days after receiving the plasma and physicians were thrilled at her improvement, but they can’t say for sure if the plasma is definitively what helped her – for two reasons.

    “We know convalescent plasma is safe but we don’t know if it really works, because no large randomized clinical trials on the treatment have been completed,” said Luis Ostrosky, MD, professor of medicine and epidemiology at McGovern Medical School at UTHealth and medical director for epidemiology at Memorial Hermann-TMC. “A randomized trial is the gold standard of research and has to be done to know for sure if the treatment is effective.”

    Ostrosky is part of team at UTHealth that just received more than $8 million from the National Institutes of Health to investigate whether convalescent plasma is effective in COVID-19 patients. The grant funds a randomized, Phase II clinical trial, meaning researchers won’t know if patients received the treatment or placebo.

    Hajjar received the convalescent plasma under a UTHealth expanded use research protocol through the Mayo Clinic. Recently, the U.S. Food and Drug Administration announced convalescent plasma would shift to emergency use, meaning the treatment would fall outside the framework of research and more hospitalized patients would have access to the treatment.

    “Under emergency use authorization, the treatment does not fall under research but the patient still has to sign to say that they know it is not a proven therapy,” said Ostrosky, vice chair of healthcare quality with McGovern Medical School and an infectious disease specialist at UT Physicians. “It is good in the sense that more patients could have access to treatment, but could also make it harder to conduct the randomized trial for researchers to assess its efficacy.”

    The other reason researchers can’t definitively attribute plasma to Hajjar’s recovery is her participation in another clinical trial while in the ICU.

    Hajjar enrolled in a UTHealth study in which researchers are investigating whether leronlimab, a treatment used for patients with HIV, can help COVID-19 patients. The trial is randomized and blinded, so physicians don’t know for sure if she got the treatment or not.

    “Heba’s case really demonstrates the benefit of care in an academic setting, and Houstonians are fortunate to have access to so many research studies through collaboration with academic institutions across the city. By seeking care from a UTHealth physician at UT Physicians or Memorial Hermann, patients have access to all the latest treatments available for even new and emerging diseases. We are staying on top of the research and contributing to the research to help as many patients as we can in the fight against COVID-19,” said Bindu Akkanti, MD, associate professor of critical care medicine with McGovern Medical School, pulmonary medicine specialist at UT Physicians, and attending physician with Memorial Hermann-TMC.

    While she wishes it could have been under better circumstances, Hajjar says she is grateful to have had the chance to participate in COVID-19 research that could have saved her life.

    “Dr. Akkanti is amazing. She’s so sweet and you can tell she cares about her patients and has such a love for science. She kept up with me and my family through text even after our discharge to make sure we were doing OK. You can tell she’s just excited to help her patients,” Hajjar said.

    Now Hajjar is considering donating convalescent plasma herself to pay it forward. Anyone interested in donating blood or plasma can visit giveblood.org.

    www.uth.edu/news/story.htm?id=476e13e...
  8. forum rang 5 MisterBlues 6 september 2020 10:46
    Enkele goede posts geplukt van diverse fora:

    IncellKLINE / diagnose kits

    Dr Bruce Patterson on the IncellKLINE and incellCEPT CCR5 RO kits : "First kits will ship Tuesday for US and EU"

    "IncellKINE Kit is for 14 cytokines and chemokines that can also be used to diagnose and treat long haulers. The incellCEPT CCR5 RO Kit is for quantifying CCR5 and determining CCR5 receptor occupancy"

    twitter.com/brucep13/status/130233774...

    twitter.com/brucep13/status/130227133...
    Now I’m getting a little excited. Keep hope alive! Woohoo! No reason to ship kits to US now if the drug won’t be available for many more months (if it would be held up by trials). This seems awfully significant. Especially given the fact that diagnostics have an expiration date, and I doubt most companies would purchase them just for them to be viable for a shorter period of time once the drug finally arrives.

    11 hours ago
    First kits will ship Tuesday for US and EU!--per tweet. Also followup was asked about shipping kits to Canada--he said absolute just looking for right contacts
    also tweeted --IncellKINE Kit is for 14 cytokines and chemokines that can also be used to diagnose and treat long haulers. The incellCEPT CCR5 RO Kit is for quantifying CCR5 and determining CCR5 receptor occupancy #incelldx
  9. forum rang 5 MisterBlues 6 september 2020 10:48
    Enkele goede posts geplukt van diverse fora:

    Complicating factors with any buyout

    There are some complicating factors with any buyout.

    1. Leronlimab sales will pay out a royalty to Progenics, the company CYDY/ bought the molecule from. Amount is 5% of sales.

    2. CYDY owes Progenics $5 million on FDA approval.

    3. Vyera gets 50% of all US HIV sales.

    4. There are 568 million shares outstanding. And even more total. That does a couple things. It gives buyers pause and it lowers any price we will receive from a buyer. Let's say after all the approvals and analysis of potential sales a buyer determines the company is worth $25 billion. That's only $44 a share. I'm not sure how to account for the other shares not part of the "float" but there are several hundred million so that potentially could lower the price.
  10. forum rang 5 MisterBlues 6 september 2020 10:51
    Nog een goede post

    Production of Leronlimab:

    1. mABs are extremely difficult to develop and manufacture. Even if we have other companies working on a new mAB, it will easily take them between 6-10 years with success rate of less than 1% to find another mAB similar to Leronlimab.
    2. Samsung manufactures nearly 70% of all current mABs on the market and has excellent regulatory and manufacturing history. They have been inspected several times by international regulatory agencies including FDA, MHRA etc. This will make any regulatory agency very comfortable with respect to Cytodyn product.
    3. As all of the regulatory agencies have inspected and approved Samsung for other products, they only need to inspect Leronlimab related specific activities, which will be much faster.
    4. Regulatory agencies look for quality, efficacy, safety, toxicity, stability etc. when approving any new product. As Cytodyn had filed BLA for HIV, they must have already covered all these aspects in their application even though it was for HIV.
    5. FDA and MHRA is now only looking for Covid related efficacy and can use the data from other trials to assess the manufacturing, toxicity etc. This is also mentioned in the EUA guidance by FDA.
    6. I have read several posts related to the SP and when to sell or how long to keep. My two cents: As Cytodyn is not one product company, but rather a platform technology company, it will certainly get acquired within 12-18 months by companies like Gilead, Genentech or Pfizer as Cytodyn portfolio matches their current portfolio.
    7. I plan to get my investment out once the COVID related SP price adjustment has taken place. I believe NP assessment of $25-30 just for COVID and plan to sell my partial portfolio at the time to recoup my investment.
    8. I agree with all other longs that this is a life time investment and we may never get similar opportunity in the future!
  11. forum rang 5 MisterBlues 11 september 2020 08:26
    Van het SA forum over BLA en MHRA - leeswaardig:

    I listened to the meeting 2nd time. I want to emphasize 4 things I feel many people missed:
    1) On August 14th Cytodyn applied for fast track approval to MHRA(=UK FDA). The MHRA responded on August 24th: "We have REVIEWED(!!!) your request and are sending your request to senior management team in LICENCING(!!!) division for further input... "
    After that, they got an update on 27th from MHRA:
    "MHRA is granting a 1-hour tele-confenrence to discuss ROUTE TO MARKET(!!!) for leronlimab in the UK..."
    Amarex said this meeting is equivalent to pre-BLA meeting with FDA and MHRA is requiring BLA submission package ESPECIALLY regarding MANUFACTORING(!!!). Cytodyn will review the package which was prepared by Amarex and submit it by Friday.
    Pay attention to those words boys and girls. I think LL passed safety&efficacy requirements from MHRA, September 9th meeting will be about manufacturing and licencing!!!
    Finally NP said: We have a STRONG CASE for fast track approval.
    2) NP said: "FDA indicated decision is FORTHCOMING(!!!)".
    That means FDA did not reject and they are seriously considering EUA approval. Sure they are moving slower than we hoped for, but I take "decision is FORTHCOMING" rather than straight rejection any day all day.
    3) They will apply to UK for HIV combination and MONOTHERAPY. Correct me if I'm wrong, but currently there is NO monotherapy drug against HIV. Monotherapy market is 3-4 times bigger than the combo market and worth about 7-9 billion yearly.
    4) Daniel Adams from Creative MicroTech said "My company specializes blood based biopsy. In the past 10 years we have we focused specifically communication aspect of the tumor cells and protumorigenic macrophages... Encompassing a few hundreds different cancer patient subtypes, CCR5 is expression is the most common both in circulating tumor cells and protumorigenic macrophages... Based on the previous hundreds of cancer patients (if not THOUSANDS(!!!)) across broad range of cancer subtypes, without the context of Leronlimab, PATIENTS WITH DIMINISHED CCR5 EXPRESSION is ALWAYS(!!!) associated with FEVER MIGRATORY TUMOR CELLS AND BETTER CLINICAL OUTCOMES(!!!). Our models have clearly shown that treatment with LL will PREVENT FURTHER PATIENT PROGRESSION.
  12. forum rang 5 MisterBlues 11 september 2020 08:28
    En de show 'must go on':

    VANCOUVER, Washington, Sept. 10, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Dr. Jacob Lalezari, CytoDyn’s Chief Science Advisor and CEO of Quest Clinical Research, will host an investment community conference call on Wednesday, September 16, 2020. The invited guests are Dr. Kush Dhody, Director of clinical trials at Amarex Clinical Research, CytoDyn’s clinical research organization, and Dr. Nicholas Agresti, whose patients received leronlimab under the U.S. Food and Drug Administration (FDA) emergency IND (eIND) program. Dr. Dhody will discuss the very successful FDA meeting concerning CytoDyn’s upcoming HIV BLA submission and Dr. Agresti will speak about the experience of his patients who received leronlimab.

    CytoDyn will also provide an update on the ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA) for leronlimab as a treatment for COVID-19.

    Management will dedicate approximately 45 minutes to address questions from analysts and investors.

    Date: Wednesday, September 16, 2020
    Time: 1:00 pm PT / 4:00 pm ET
  13. forum rang 5 MisterBlues 13 september 2020 11:42
    quote:

    MisterBlues schreef op 11 september 2020 08:28:

    En de show 'must go on':

    VANCOUVER, Washington, Sept. 10, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Dr. Jacob Lalezari, CytoDyn’s Chief Science Advisor and CEO of Quest Clinical Research, will host an investment community conference call on Wednesday, September 16, 2020. The invited guests are Dr. Kush Dhody, Director of clinical trials at Amarex Clinical Research, CytoDyn’s clinical research organization, and Dr. Nicholas Agresti, whose patients received leronlimab under the U.S. Food and Drug Administration (FDA) emergency IND (eIND) program. Dr. Dhody will discuss [b]the very successful FDA meeting concerning CytoDyn’s upcoming HIV BLA submission [/b]and Dr. Agresti will speak about the experience of his patients who received leronlimab.

    CytoDyn will also provide an update on the ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA) for leronlimab as a treatment for COVID-19.

    Management will dedicate approximately 45 minutes to address questions from analysts and investors.

    Date: Wednesday, September 16, 2020
    Time: 1:00 pm PT / 4:00 pm ET
    Opmerkelijk taalgebruik. Vooral het woord very, dat ik erg vaag vind voor een wetenschappelijk bedrijf. Is volgende BLA meeting dan ultra succesful? Of wordt er een stapje teruggenomen: moderate succesful? Of bedoelen ze te zeggen dat het succesful was, en dat er een doorbraak is en dat de BLA nu zo goed als zeker op de rails staat? Je zou zeggen van wel, maar Naders manier van bedrijfsvoering en zijn PR-machine slaan alles.

    Ongoing discussions met de MHRA is dan een kwalificatie die betekent dat het nog alle kanten op kan...?

    Nog steeds geen peer-review.
  14. forum rang 5 MisterBlues 17 september 2020 10:51
    Wat betreft de BLA is het duidelijk dat ze nu precies weten wat de FDA wil en dat deze gegevens er al zijn. Kortom: helemaal niets nieuws.

    Het is denk ik verstandiger om gewoon te wachten tot ze echt iets voor elkaar hebben gekregen bij de rest van de wereld zoals FDA etc. Laatste post want ik word niet goed van die Nader.

    De huidige stand der dingen CYDY
    beschreven door een zekere Robert van YF:

    What we learned today significantly derisked Cytodyn on multiple fronts as well as increased the total addressable market substantially. The shorts and AF’s of the world will spin it, but here are the key points to keep in mind:

    1. For Covid EUA and MHRA we now have a definitive answer that the CD12 interim results are needed. We also have solid indication based on the eIND and M/M testimonies that CD12 will show meaningful results. We know that CYDY continues to have both the attention of the FDA and MHRA on these results as evidenced from the FDA guidance on the EUA and the MHRA ask for eIND data. We also know the route that is likely in the UK is EAMS which is the same route that remdesivir was approved. Prior to the call the FDA response was unknown and the MHRA response was conjecture on everyone’s part.

    2. We have clarity on the go forward with M/M to complete a phase 3 trial to go for marketing approval. CYDY is defining this to also enable endpoints related to long haulers (eg., another form of mild/moderate). Given the lack of any viable treatment for long haulers and growing number of potential patients, the market potential is sizeable.

    3. We now have the specifics need for the BLA application and confirmation that the data already exists based on the study to date. While CYDY has learned the challenge of giving dates, we can assume it’s weeks not months and that there’s very strong chance given the Type A meeting that the BLA filing will be accepted. We also have potential upside in UK approval for HIV mono therapy (though not specifics).

    4. We have a green light at a start date In early October for the first Phase 2 NASH trial and a sizeable potential market size (I believe in the $20B).

    5. We have proof of the potential market size of monoclonal antibodies through the recent $20B acquisition for a drug that has significant side effects and only applications in cancer as well as only one drug approved after 35+ years of research. One can easily see leronlimab being a multiple of this.

    6. We have a strong evidence of leronlimab’s potential in strokes, Parkinson’s and other brain related diseases based on the recent finding that leronlimab does, in fact, cross the blood-brain barrier and achieves 75% occupancy of CCR5 receptors. This significantly increases the potential market size of leronlimab.

    7. We understand NASDAQ is an when not if and any major event such as a drug approval for Covid or a PFUDA date will have a significant impact on stock price and overall valuation.

    8. Finally, we see CYDY making investments in adding employees. (I for one do hope they hire quickly for a top notch investor relations person for no other reason that the PR/IR mistakes and judgement errors are creating too many distractions!)

    I for one am looking at really just two key milestones: the CD12 interim results and the HIV BLA FDA submission. NASDAQ an added bonus but not expecting it nor worried about it happening.

    Everything else is noise at least at this point in their company lifecycle.
  16. [verwijderd] 18 september 2020 21:20
    Het is wel duidelijk dat Leronlimab niet goedgekeurd mag worden. Ik geloof beslist in de uniekheid van Leronlimab, maar de politieke druk om het niet goed te keuren is ongekend groot. Daarom zal één en ander veel langer duren dan gepland. Er zal verder verdund worden. Daarnaast vind ik de hebberigheid van Nader Pourhassan niet gepast.

    En de belangrijkste persoon Dr. Bruce Patterson is niet meer betrokken bij CytoDyn. Al deze factoren heeft me doen besluiten om helemaal uit CytoDyn te stappen.

    fc
  17. Dappie 18 september 2020 23:57
    Jammer om je te zien ‘gaan’. Apprecieerde zeer jouw posts. Mijn instappunt ligt veel later en hoger.
    S/C tussentijdse resultaten komen er aan. Dat LL de Blood/Brain grens weet te doorbreken is uitstekend nieuws. Die hebberigheid ben ik het mee eens. Maar ik blijf er in geloven en blijf long met een voor mijn doen toch zware positie.
    Lange maar interessante post:
    talkmarkets.com/content/stocks--equit...
  18. Dappie 19 september 2020 01:00
    En ben het volmondig eens met:
    In retrospect there were likely 3 distinct PRs they could have gotten out of the CC and not held the CC...a) testimonials for eINDs b) LL crosses the BBB to support patients with CV that has pathogens in Brain. and c) CytoDyn reaches agreement with FDA on acceptance of 700MG study done for 1 year and no additional data or trials required
  19. forum rang 5 MisterBlues 19 september 2020 10:33
    quote:

    Dappie schreef op 19 september 2020 01:00:

    c) CytoDyn reaches agreement with FDA on acceptance of 700MG study done for 1 year and no additional data or trials required

    FC en Dappie,

    Ook ik vind het gek om de persoon die me enthousiasmeerde in het begin van de pandemie voor Cydy te zien ‘gaan.’Het verbaast me niet gezien je GAK, het gedrag van Nader en het (voorspelbare) vertrek van BP die sowieso niet part of the crew was maar consultant / adviseur.

    Dankzij de opgedane kennis bij Cydy vond ik Relief en daarmee heb ik wel enorme winst gemaakt. Dat heeft het verloren beleggingsseizoen enigszins goed gemaakt.

    Je generalisatie dat Leronlimab niet goed gekeurd gaat worden zou wel eens binnen anderhalve maand gelogenstraft kunnen worden: Cydy heeft nu een harde toezegging dat de BLA wordt toegekend door FDA voor de hoge dosis als de gegevens maar worden bijgeleverd. Eerst was die harde toezegging er nog niet.

    Planned U.S. marketing application in treatment-resistant HIV-1 to be based on 700 mg dose. The Phase 3 study (CD02) was conducted with 350 mg dose, however. A different Phase 3 (CD03) assessed three doses of leronlimab alone (350 mg, 525 mg and 700 mg) in virally suppressed CCR5-tropic HIV-1 patients. Company says the agency has agreed that the 700 mg dose is the one that it will approve but wants to see data from an ongoing monotherapy study to demonstrate efficacy. All patients in this dose arm in CD03 have completed treatment so management believes it has the necessary data to support a BLA filing.

    Mochten die gegevens niet aangeleverd kunnen worden dan begint het toch echt te lijken op mismanagement en/of (halve) oplichting.

    Ik heb met mezelf afgesproken dat de BLA op de rails moet staan en de uplisting een feit - voor 31 december 2020. Voor de rest steek ik er geen tijd meer in.

    MB
  20. [verwijderd] 20 september 2020 10:19
    Voor de zittenblijvers, ik hoop dat ik helemaal ongelijk heb en dat Leronlimab goedgekeurd gaat worden.

    Maar ik vind het gedoe om HCQ heen een uiterst slecht voorteken. WHO wil eenvoudigweg geen werkend medicijn. En de FDA wil geen werkend HIV medicijn. Constant wordt de boel vertraagd.

    Tegen Covid: Vitamine D en zink werken als een tierelier, en er wordt niet over gesproken. Ivermectine en HCQ/zink worden in veel landen gebruikt. Werken ook als een tierelier in de virale ziekte. Mag in Nederland en veel andere landen niet gebruikt worden.

    Het lijkt of we geen werkend medicijn mogen krijgen. Voor alle duidelijkheid, Leronlimab is een super medicijn. Ik zie het alleen niet binnen afzienbare tijd op de markt komen, en daarmee verwacht ik dat de koers verder onder druk komt. En Nader helpt daar niet bij met zijn flut communicatie.

    Betreffende Dr. Bruce Patterson, hij was inderdaad niet in vaste dienst, maar hem op afstand is een uiterst slechte ontwikkeling...

    fc
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