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Heeft CytoDyn het ultieme anti-HIV-middel??

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  1. forum rang 5 MisterBlues 25 november 2020 11:17
    From the amfAR news:

    As part of the agreement, CytoDyn will provide leronlimab and study support,
    while amfAR will support groundbreaking study sites to incorporate leronlimab
    in their cure studies.

    One of their Collaboration Institutions is IDRI --- Infectious Disease Research Institute.

    From Infectious Disease Research Institute website:
    * Pharma company foundation : Fundao Oswaldo Cruz (Fiocruz)

    * Private foundation or development organization:
    Bill and Melinda Gates Foundation
    Fundao Oswaldo Cruz (Fiocruz)

    Everyone knows BGF.

    Fundao Oswaldo Cruz (Fiocruz) ---- Founded 1900; The Oswaldo Cruz Foundation is a
    scientific institution for research and development in biological sciences located in Rio
    de Janeiro, Brazil, it is considered one of the world's main public health research institutions.

    Aug. 2019, CytoDyn plan was to inject 5 to replicate Timothy Brown & Adam Castillejo.
    Double or more, is a serious head-to-head statement.
    Just like going 2:1 on Covid.

    There would absolutely be high caliber Executive additions.

    Leronlimab continues to perform through amfAR, and CytoDyn partners into the worlds
    best HIV / research organizations.
  2. forum rang 5 MisterBlues 29 november 2020 11:40
    Ik vraag me af of dit Long Hauler studie (fase 2) zin heeft. Het gaat om vage klachten:

    November 27, 2020
    Danielle Ternyila

    A protocol has been filed with the FDA for a phase 2 clinical trial aimed to evaluate leronlimab, which has been used to treat various solid tumors and hematologic malignancies, as treatment of patients with coronavirus disease 2019 who are suffering from long-hauler symptoms.

    A protocol has been filed with the FDA for a phase 2 clinical trial aimed to evaluate leronlimab (PRO 140), which has been used to treat various solid tumors and hematologic malignancies, as treatment of patients with coronavirus disease 2019 (COVID-19) who are suffering from long-hauler symptoms, according to a press release from CytoDyn Inc., developer of the drug.

    The CCR5 antagonist will be evaluated in 102 patients enrolled in up to 10 sites, according to the protocol for the study, entitled, “A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers].” The study will include an interim analysis after half the patients are enrolled and will allow CytoDyn to report the data.

    The therapeutic benefit of leronlimab in patients with COVID-19 has been demonstrated in another recent study, the phase 2 CD10 clinical trial of leronlimab for mild-to-moderate COVID-19.

    “We are very pleased to be able to finalize this protocol and submit today. Many thanks to Drs. Chris Recknor, Mahboob Rahman, and Kush Dhody for spending countless hours over the last 6 weeks finalizing this very challenging trial protocol. Dr. Recknor’s past enrollment of patients in our CD10 trial was critical to his understanding of what leronlimab can do and his experience with those patients greatly assisted us to design and finalize this protocol,” said Nader Pourhassan, PhD, president and chief executive officer of CytoDyn, in a statement.

    About 10% of patients with COVID-19 have become long-haulers, and published studies and surveys have indicated that 50% to 80% of patients continue having troublesome symptoms 3 months after onset of the virus, even lasting later than when tests can detect the virus in the body. Long-hauler symptoms form an extensive and inconsistent list as for some people, lingering symptoms are nothing like the original symptoms when they were first infected.

    The most common long-hauler symptoms include coughing; ongoing, sometimes debilitating, fatigue; body aches; joint pain; heart issues; shortness of breath; loss of taste and smell; difficulty sleeping; headaches; and brain fog.

    “If successful, this phase 2 trial could potentially allow leronlimab to be the first treatment for patients experiencing these debilitating symptoms and perhaps their only hope for full recovery,” Pourhassan stated. “We have become very knowledgeable of leronlimab’s potential for COVID-19 patients due to our completed phase 2 trial for mild-to-moderate symptoms, for which a complete report has been submitted to a very reputable journal for publication.”

    The phase 2 CD10 clinical trial was a double-blinded randomized study of leronlimab as treatment of patients with mild-to-moderate COVID-19, and the agent induced statistically significant findings with a reduction in the National Early Warning Score 2 (NEWS2) at day 14. The findings were recently shared during a presentation during the Special isirv-Antiviral Group Conference on ‘Therapeutics for COVID-19’ and demonstrated its potential to prevent progression to severe or critical disease.2

    In the CD10 study, no differences in oxygen use or hospitalizations were observed between the leronlimab and placebo arms, although this may have been limited due to exclusion of patients with pre-existing medical conditions, such as severe pulmonary, liver, and renal disease who have been to be at higher risk of COVID-19 progression and overall mortality.

    The Total Symptom Score at baseline was =4 in 53.6% of patients and >4 in 46.4%. Most patients (76.2%) did not receive any off-label COVID-19 treatments, and 61.9% were aged <60 years, and the majority (66.7%) had never smoked.

    In terms of toxicity, adverse events (AEs) of any grade were seen in 33 patients (39.3%), while mild events occurred in 17 (20.2%), moderate in 8 (9.5%), and severe in 8 (9.5%). incidence, frequency, and severity of AEs were lower with leronlimab compared with placebo, in which AEs of any grade were observed in 19 patients (33.9%) versus 14 (50.0%), of mild severity in 12 (21.4%) versus 5 (17.9%), moderate in 2 (3.6%) versus 6 (21.4%), and severe in 5 (8.9%) versus 3 (10.7%), respectively. Eight serious AEs occurred in 56 patients (14%) in the leronlimab arm compared with 11 in 28 patients (39%) from the placebo arm.

    Overall 11 patients (13.1%) experienced treatment-emergent AEs (TEAEs), including 5 (8.9%) in the leronlimab and 6 (21.4%) in the placebo arm. TEAEs that were possibly related to study treatment were observed in 2 pa

    I am NOT convinced that this is wise. How do you devise a Primary Outcome from

    "The most common long-hauler symptoms include coughing; ongoing, sometimes debilitating, fatigue; body aches; joint pain; heart issues; shortness of breath; loss of taste and smell; difficulty sleeping; headaches; and brain fog."

    with 102 subject at 10 sites.

    Do you know how much it cost for "countless hours over the last 6 weeks finalizing this very challenging trial protocol?". Those three people were not the only authors and reviewers, either.

    Without revenue, then CYDY needs to have razor focus.
  3. forum rang 5 MisterBlues 8 december 2020 20:48
    quote:

    Dappie schreef op 8 december 2020 17:55:

    emerginggrowth.com/cracking-the-fda-c...

    Eindelijk weer eens wat push up. 28% stijging vandaag!

    Meer triggers komende tijd:

    1. BLA filings
    2. Long Hauler Trial Confirmation by FDA
    3. Philippines EUA application filing
    4. CD12 enrollment completion or 75% interim data peek announcement
    5. Leronlimab combination with Vaccine announcement
    6. Funding out of left field
    7. Amarex and Dr. Kush Dhody Covid scientific board / collaboration announcement
    8. EUA application filing anywhere else
  4. Dappie 8 december 2020 21:19
    Dat het CMS nu Leronlimab een code heeft toegekend wijst er toch op dat ze nu als een echte kanshebber gezien worden voor een FDA approval of EUA. Het doet de koers goed. Afwachten nu wat de CC van donderdag brengt.
  5. forum rang 5 MisterBlues 9 december 2020 00:09
    quote:

    Dappie schreef op 8 december 2020 21:19:

    Dat het CMS nu Leronlimab een code heeft toegekend wijst er toch op dat ze nu als een echte kanshebber gezien worden voor een FDA approval of EUA. Het doet de koers goed. Afwachten nu wat de CC van donderdag brengt.
    Ja eindelijk weer een CC waar ik echt zin in heb en ga kijken ook nog.
  6. forum rang 5 MisterBlues 9 december 2020 11:37
    quote:

    Dappie schreef op 8 december 2020 21:19:

    Dat het CMS nu Leronlimab een code heeft toegekend wijst er toch op dat ze nu als een echte kanshebber gezien worden voor een FDA approval of EUA. Het doet de koers goed. Afwachten nu wat de CC van donderdag brengt.
    Dat CMS gaat niet over FDA approval maar het is wel een positief signaal.

    Intussen een zekere Buck op een ander forum:
    From another Revcycle Intelligence article: “Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,” CMS Administrator Seema Verma said in yesterday’s announcement. “Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings – such as in a doctor’s office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives.”

    Frank antwoord:

    Amazing this courage ! They do that before FDA grants EUA. Bypassing FDA because of potentially life saving. They also must have done some safety assessment.

    Actually CMS did. already what FDA should have done by now !!
  7. forum rang 5 MisterBlues 9 december 2020 11:40
    Een zekere ying plaatst een rapport naar een onderzoek over medicijnvergoedingen via CMS die NIET FDA goedgekeurd zijn.

    Overigens is de CMS toewijzing wel gekoppeld aan goedkeuring FDA

    One Percent of Drugs With Medicaid Reimbursement Were Not FDA-Approved

    oig.hhs.gov/oei/reports/oei-03-17-001...
  8. forum rang 5 MisterBlues 9 december 2020 11:43
    Een zekere TI op een ander forum over de toenname van de handel en CMS:

    $3.27 SP close up 32% on 11.7 million volume, more than 10x yesterdays volume. At 4:03:36 967,456 shares were traded at $2.9815 which indicates an institutional VWAP trade and was very close to the VWAP price shown on Fidelity at the close. As you may recall, VWAP means volume weighted average price (for the day). An institution can put in an order with a broker before the end of the day for x shares at the vwap closing price. That is why you get a very precise 4 digits after the decimal points for this almost million share trade.

    The price movement and volume appears to be a reaction to the CMS providing a DRG Code for leronlimab, along with Pfizer and Moderna vaccines, effective January 1 so Medicare and Medicaid can reimburse for leronlimab starting after January 1 if it is approved. We know FDA have been following the leronlimab trials carefully. Dr. Janet Woodcock, FDA's representative on OWS confirmed that to me in an email weeks ago.

    The government would take this pre-emptive DRG designation action to be ready to reimburse for leronlimab if FDA did not think the likelihood of a leronlimab EUA were not promising. Given the success with CD010 and 60 eINDs, I am sure all the longs would agree with this assessment. Seems like today's little price and volume jump indicates that the investment community is starting to realize that leronlimab is the real deal as well.

    Thursday's conference call should shed some more light on realistic time frames for a possible EUA or full approval. This largely depends on how quickly they can gather and analyze the data from the 293 and then 390 patients when enrollment is complete. This is largely a logistical problem as I understand it.
  9. Dappie 16 december 2020 11:11
    CytoDyn Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19
    December 15, 2020 4:01pm EST
    CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients

    VANCOUVER, Washington, Dec. 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.

    On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.
  10. forum rang 5 MisterBlues 17 december 2020 10:35
    Na goedkeuring moet er ook geleverd kunnen worden en dat lijkt wel goed te zitten.

    Van Cooka, 16 dec:

    Where all of this is important is regarding the FDA's comfort level with a new drug, while NP ensures an immediate and adequate supply of Leronlimab upon authorization. He's walking a tight rope between nudging the FDA to hurry without pressuring the agency to act with a bad taste in its mouth; something, sure to hurt us in future indication applications.

    You see, I did some research into the process of manufacturing mAbs. I discovered that the full process could take 5 months, before product was received by the customer. The one part of the process, which took the longest amount of time was the procurement of the hybridoma cell line seed stock. From injecting the mice with an antigen to obtaining a small vial of hybridoma cell seed stock was shown to be about 3 to 3.5 months until completion. Once the seed stock was available, the process to grow the seed stock to 2,000L takes about 2-3 weeks. Then, there's bottling, packaging and shipping.

    Concerned with a potential gap of 5 months between batches, I contacted NP regarding the availability of an adequate supply of hybridoma cell seed stock to support large scale production. He replied that they had that 100% complete, and were prepared to move for large-scale manufacturing.

    As a result, we are in an excellent position to fully supply the US with an adequate supply of Leronlimab. And, I'm sure there have been discussions regarding the necessary amount of Leronlimab, which will be required for the US to procure, once an authorization is in hand.


    Van Pbio en Mel 16 dec:


    Cytodyn will be manufacturing Virologix at Samsung Biologics, which is one of the best manufacturing site for biotech products. They have capacity to manufacture over 364,000 L of any product at their full capacity. As they are manufacturing more than 50% of products currently sold in USA (Amgen, Gilead. Merck etc.), they have excellent regulatory compliance history. Also, they have flexible manufacturing set up, which means that they can ramp up production of any product very fast. Usually it take 2-3 weeks to produce mABs and therefore, we can have multiple batches manufactured every three weeks, if required. I am not at all worried about the ability of Cytodyn to provide the additional product, if required. NP selected the best manufacturing site for their product with highest chances of success!


    Mel


    Yes, they are the largest manufacturer in the world. Here is a new article about their expansion plans.

    endpts.com/samsung-biologics-promotes...
  11. forum rang 4 nb 17 december 2020 17:08
    Gaat het gebeuren.....?
    Was eruit gestapt, maar zie toch nu kansen.
    Bedankt voor de nimmer aflatende inbreng, MB.!
  12. forum rang 5 MisterBlues 17 december 2020 18:29
    quote:

    nb schreef op 17 december 2020 17:08:

    Gaat het gebeuren.....?
    Was eruit gestapt, maar zie toch nu kansen.
    Bedankt voor de nimmer aflatende inbreng, MB.!
    Vergeet Dappie niet, en ik doe de plaatsingen vooral voor mezelf; kan ik het nog eens rustig nalezen. ;-)

    Toch graag gedaan.\

    Ja, idd, het lijkt toch de goede kant op te gaan. Wat severe & critical betreft zou er nu goedkeuring kunnen komen uit USA, UK en Philipijnen. Zo hebben ze de FDA minder hard nodig en onder druk.

  13. forum rang 4 nb 17 december 2020 20:37
    zit er voor 4% van mijn geheel in. mooie kans/gok
  14. forum rang 5 MisterBlues 18 december 2020 12:09
    Bruce Patterson is een echte wetenschapper zonder aandelen in Cydy.

    Eindelijk een peer reviewed artikel op een gezaghebbende site.

    , Harish Seethamraju and Kush Dhody’s article published in International Journal of Infectious Diseases. Search - CCR5 inhibition in critical covid 19 patients.

    Highlights:

    • Anti-CCR5 humanized monoclonal antibody restored CD8 counts in COVID patients.?•?Inversely correlated with decreases in plasma viral load (pVL) by day 14.?•?CCL5/RANTES up 3–5-fold in mild/moderate patients and >100-fold in critical ones.?•?First report of highly sensitive, quantitative pVL by ddPCR in COVID patients.?•?Statistically significant drop in IL-6 by day 14 of treatment.

    Here is the link: www.ijidonline.com/article/S1201-9712...
  15. forum rang 5 MisterBlues 18 december 2020 12:13
    Aanstaande?

    • Philippines EUA Relevant to CytoDyn, not Humanigen
    • Highly Credentialed Humanigen Team
    • Possibility of NASDAQ Uplisting for CytoDyn Over $4.00
    • Impact of Regulators on Stock Price
    • Possibility of DSMC Intervention Next Week

    The top two COVID-19 therapeutics candidates in the approval pipeline seem to be sparring. Yesterday both Humanigen (NASDAQ: HGEN) and CytoDyn Inc (OTCMKTS: CYDY) gave enrollment updates and ignited a firestorm within investor social media forums about the likelihood of an Emergency Use Approval (EUA) in the Philippines. Humanigen started off with their conference call at 12:00PM EST and revealed that they enrolled 423 of the 515 patients needed to complete their trial. At the closing bell CytoDyn announced it had reached full enrollment with 390 patients and planned to readout a month later. During the investor call the CEO of Humanigen, Cameron Durrant, MD said that an EUA would be needed in the USA before filing for one over in the Philippines based on his experience. This view was immediately challenged after the bell by CytoDyn’s

    CEO Nader Pourhassan who said:

    “Since the Philippine FDA has relaxed the criteria of EUA for any safe drug with any efficacy data, we will file our EUA as soon as the presidential order is implemented by the Philippine FDA with all of the information we currently have available, which we believe could occur within the next couple of weeks.”
    CytoDyn believes their drug leronlimab meets the safe and possibly effective criteria established by the executive order and a quick fact check of the order reveals that he is indeed correct.
  16. forum rang 5 MisterBlues 18 december 2020 12:15
    Over het handelsvolume en de ECHTE trigger:

    Strong gain, 19% to $4.6765 today on strong volume (7.4 million shares). Looks like the investor pool is broadening out. 750k of green block trades earlier today at $3.95 and $4.00. They did very nicely today.

    Once CYDY announces the Philippine EUA filing, I think we will see another pop. But the real moves won't begin until approval in Philippines and U.S., UK, Canada, EU etc. Of course if Philippine buy the $2.5 billion of leronlimab available at the end of this month, that will further boots the stock, likely by multiples since $2.5 billion would be close to the market cap of CYDY fully diluted (700 million shares) at today's closing price. It will be seen, and rightly so, as a harbinger of bigger things to come.

    In sum, today's nice trading action is likely only a very preliminary move. If you sell now, you will miss out on the real party over the next couple of months.
  17. Dappie 18 december 2020 14:35
    Veel quotes uit Yahoo forum. Maar ook ik volg ‘het’ vooral via die weg.
    Stond paar weken geleden op fors verlies (ruim -20k), wilde nog bijkopen, maar heb naar mijn vrouw geluisterd... Inmiddels groen, en had achteraf gezien toch bij moeten kopen.
    Al kan het ook nu nog alle kanten uit.
    Als de cd12 trial hun primair eindpunt haalt (enige s/c met mortaliteit als primair einddoel) gaat het dak er nog af. Maar aangezien de SOC laatste maanden beter is dan in begin trial is het de vraag of ze met 390 personen statisch significante resultaten behalen. Ik denk dat er enkele maanden geleden relatief meer overlijdens waren. Maar de kans is reëel dat ze met een EUA aanvraag voor cd10 in de Filipijnen een eerste succes boeken, waarbij er eindelijk geld in de lade komt. Ze zouden voor 2mrd aan voorraad hebben, ongeveer hun beurswaarde. En er zijn aanzienlijke schulden op korte termijn te betalen.
    Op 21 dec valt de 28 dagen na 75% enrollment. Cydy vraagt zeker zelf geen unblinding. Dsmc zou zelf interim kunnen doen, maar is weinig waarschijnlijk.
    Zo zou Corona dan toch tot commerciële resultaten kunnen leiden, en is het niet wachten op BLA HIV met de onzekerheid of ze dat financieel redden.
    Overheid usa heeft ze in ieder geval nooit geholpen. Integendeel. Maar als ze echt met bewezen verlaging mortaliteit uit kunnen pakken kan men hen toch niet blijven negeren of tegenwerken?
  18. Dappie 18 december 2020 14:59
    Een flink stuk van de recente felle stijging zal ook wel te maken hebben met shorters die hun posities (tijdelijk) afsluiten. Als big pharma er mee achter zit volgt wellicht nog een aanval om de koers onder de 4$ te krijgen (Nasdaq).
    Maar wie gelooft in de wetenschap... zou zich hierdoor niet uit het lood mogen laten slaan. Ik blijf nog steeds long. En duimen voor positieve trialresultaten.
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