Heeft CytoDyn het ultieme anti-HIV-middel??

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Dappie
1
Onderstaande zou dus ook Cytodyn parten kunnen spelen:

“During the course of the trial, as the pandemic has evolved, numerous changes in the treatment regiment for COVID-19 patients occurred, including both prior to and while on mechanical ventilation that may have an effect on the mortality endpoint in the trial.”

To get a statistically significant reduction in mortality unfortunately requires a lot of deaths in the placebo arm. As more therapeutics and treatment protocols became optimized the mortality rate in COVID started dropping and this made it much harder to achieve statistical significance on mortality.

Maar anderzijds: de ene zijn dood is de ander zijn brood:

There should also be a corresponding reset higher in the price of CytoDyn since they are the beneficiary of being the first to market and have outlasted all their competition. They even have 3 shots on goal in this upcoming trial readout. Their primary endpoint is 28 day mortality, their revised secondary endpoint is 42 day survival, and change in clinical status on a 7 point ordinal scale. Meeting just one of these endpoints is a layup for approval but it’s likely that they will meet all of them. As the only drug with a mortality benefit, they are almost guaranteed to be the new SOC. This will dramatically impact Gilead Sciences (NASDAQ: GILD) and their sales of remdesivir. CytoDyn might also get a label expansion in moderate COVID-19 and long haulers. They have a clinical trial for long haulers that could be started imminently. All these factors combined equate to a doubling of market cap and a doubling of price. This news could drive the stock to $10.00 in the short run.
MisterBlues
0
quote:

Dappie schreef op 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?


Het klopt dat ik beste stukken snel van Yahoo pluk. Aldaar zitten een paar goede volgers die al jaren bezig zijn met het aandeel.

Je vat het allemaal goed samen in een notendop. Ze spelen hoog spel.

Ik vind de FDA t.a.v. de Covid-19 onderzoeken wel coöperatief geweest, zeker in het begin. De kans dat ze PE mortaliteit halen lijkt me niet erg groot maar andere SE's moeten ze zeker halen en dan kan toch EUA overwogen worden zeker als de PE mortaliteit bijna gehaald is. Het is een noodtoewijzing, after all.

Philipijnse toewijzing is zeker reëel, en indien uitgevoerd met aansprekende behandelingen in de toekomst blijft het daar niet bij - zo mag je veronderstellen. Verder weet iedereen over de matige resultaten van Remdesivir. Het zal niet moeilijk zijn dat middel voor de mild en moderate CD10 groep te verslaan. Ik denk dat de Philipijnse FDA er wel oren naar heeft.

FDA heeft wel altijd heel rigide en selectief gekeken naar de HIV BLA applicatie. Daarvoor hebben ze nu wel een wetenschappelijk officier aangesteld bij Cydy om die aanpak te pareren. Bovendien loopt er nu ook een HIV BLA toekenning bij de MRSA.

Als HIV-middel is leronlimab nog steeds in de race zowel als combi-therapie en als mono...

De geldzorgen kunnen binnenkort voorbij zijn - en zolang dat niet het geval is vormen ze een tikkende tijdbom - dat dan weer wel.
MisterBlues
0
quote:

Dappie schreef op 18 december 2020 15:30:



Maar anderzijds: de ene zijn dood is de ander zijn brood:

There should also be a corresponding reset higher in the price of CytoDyn since they are the beneficiary of being the first to market and have outlasted all their competition. They even have 3 shots on goal in this upcoming trial readout. Their primary endpoint is 28 day mortality, their revised secondary endpoint is 42 day survival, and change in clinical status on a 7 point ordinal scale. Meeting just one of these endpoints is a layup for approval but it’s likely that they will meet all of them. As the only drug with a mortality benefit, they are almost guaranteed to be the new SOC. This will dramatically impact Gilead Sciences (NASDAQ: GILD) and their sales of remdesivir. CytoDyn might also get a label expansion in moderate COVID-19 and long haulers. They have a clinical trial for long haulers that could be started imminently. All these factors combined equate to a doubling of market cap and a doubling of price. This news could drive the stock to $10.00 in the short run.


Ik weet van andere Covid-19 onderzoekstherapieën gericht op Critical dat ze de PE mortaliteit allang afgeschaft hebben vanwege de verbeterde SOC.

Cydy doet het zoveel beter op alle fronten dan anderen dat een FDA goedkeuring er midden januari echt kan komen (na 42 dagen).
MisterBlues
0
quote:

MisterBlues schreef op 18 december 2020 15:44:


[...]

Ik weet van andere Covid-19 onderzoekstherapieën gericht op Critical dat ze de PE mortaliteit allang afgeschaft hebben vanwege de verbeterde SOC.

Cydy doet het zoveel beter op alle fronten dan anderen dat een FDA goedkeuring er midden januari echt kan komen (na 42 dagen).


Het klopt wat ik zeg:

What I think the real story is here - the DMSC SHUT DOWN the MESO trial, not because of safety, BUT BECAUSE IT WAS CLEAR THAT THEY WOULD NOT HIT THEIR END POINT!

Here are 6 fun facts on the CYDY Phase 3 COVID trial for S/C patients (and a 7th that I believe is factual as well):
1) The DMSC did not shut down the trial
2) The DMSC did not recommend increasing the # of patients
3) The DMSC did not recommend changing the end-point
4) The DMSC, in an unusual step, wanted to look at the trial again when it hit 75% enrollment
5) The DMSC DID ADD and endpoint it wanted to be reviewed in addition to not altering the primary endpoint
6) This trial is the FIRST to complete enrollment for phase 3 with mortality as the primary endpoint
7) This trial (to the best of my knowledge) is now the ONLY trial with mortality as its primary endpoint

MisterBlues
1
...scheurt de aanhouder door de Brennerpas...

"FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix(TM) (leronlimab) Following Full Enrollment in CytoDyn's Phase 3 Trial"
Zwartgeld
0
Dappie
1
Eerst 17% gestegen vandaag, tot 7 dollar. Piek van juli. Technische weerstand. Dan short aanval met ruim 2.5 mln stuks op paar minuten tijd, die stop losses triggerde.
Ook Sec filing van cfo die 1 mln stuks verkocht gisteren (begin nov vastgelegd plan volgens wat ik las). Als unblinding de verhoopte resultaten geeft... niets aan de hand.
MisterBlues
1
Ja TI op Yahoo schreef er dit over:

12 hours ago
Close at $5.26 down 12.25% on a whopping 23 million volume. Looks like there may have been some pumping and dumping today driving the stock to $7 and then dumping hard taking advantage of no real new News. Shorters like volatile stocks. As we all know, what will really drive the stock up is approvals and billions of revenues. We can expect to see both over the next 6 weeks.

First Philippines over the next few weeks assuming Cytodyn files the EUA application this week or so and then U.S., UK, EU after the CD012 severe to critical results are submitted to FDA and the other countries, probably mid January to early February which will then lead to massive sales in the teeth of the expanding pandemic. Medicare/Medicaid has readied themselves for approval by assigning DRG reimbursement numbers to leronlimab for Covid.

So, don't be discouraged by any amount of volatility before the approval. It's just the shorts doing their thing till the investment community as a whole gains the amount confidence in leronlimab's prospects that we longs have now.
chipmunk85
0
"FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded"

wordt spannend maandag :)
Dappie
0
Dat ze dit nu toelaten of geven is goed nieuws. Geen placebo meer bij verdere uitbreiding. FDA moet tussentijdse positieve resultaten hebben gezien. Maar die zagen ze bij de cd10 trial ook. Maar het was big pharma die met de eau’s ging lopen.
In ieder geval een positieve ontwikkeling.

FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded

Download as PDFDecember 24, 2020 7:46pm EST
The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12

The CD12 trial completed enrollment with 394 patients on December 16

VANCOUVER, Washington, Dec. 24, 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 the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company to add an open-label extension to its Phase 3 trial (“CD12”) and specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12.

The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020. Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab. Treatment of qualified patients will continue until the trial’s data is unblinded.

The FDA also provided specific guidance for the benefit of physicians seeking an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study, and such criteria will be provided to them in the form of a checklist.

Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We are pleased that at a time when COVID-19 cases and mortality continue to increase, the FDA’s thoughtful advice will allow a specified subset of patients access to leronlimab, while we await the results of the randomized placebo-controlled portion of the Phase 3 study. We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful to the FDA for providing guidance on accessing our drug pending the results of CD12, especially during these unprecedented times. CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request.”



MisterBlues
0
quote:

Dappie schreef op 25 december 2020 13:58:


Dat ze dit nu toelaten of geven is goed nieuws. Geen placebo meer bij verdere uitbreiding. FDA moet tussentijdse positieve resultaten hebben gezien. Maar die zagen ze bij de cd10 trial ook.

Maar het was big pharma die met de eau’s ging lopen.

In ieder geval een positieve ontwikkeling.




EUA.

Regeneron, convalascent plasma, Gilead hadden gewoon veel meer data om te overleggen aan de FDA. In het geval van Cydy is dat nu ook voldoende terwijl er vanuit het medische veld extra vraag is. Het aantal patiënten in kritische toestand dat overlijdt zonder L.mab blijft hoog.

FDA heeft van begin af aan contact gehouden met Cydy over de vorderingen. Ze adresseren (opnieuw) de medisch maatschappelijke behoefte en dat is één aspect van de EUA. Het ziet er goed uit. Midden januari weten we of ie er komt.
MisterBlues
0
Interessant artikel. Enerzijds is Expanded Acces een duidelijke aanwijzing dat FDA vindt dat L.mab voorziet in een behoefte die er nog niet is. Anderzijds wil de FDA ook geen kosten meer vergoeden als dat niet nodig is.


Wolfgang (Germany)

20 hours ago
from the nejm article:

Quote: "For all expanded-access categories, the FDA must determine that the condition is serious or immediately life-threatening, that there are no similar or satisfactory alternative therapies, and that access will not interfere with pivotal clinical trials.11 These caveats appropriately place primacy on the traditional FDA approval process. In addition, the FDA must determine that the potential benefits of expanded access justify the potential harms. The evidentiary threshold for this criterion increases with the number of patients who are involved and is higher for less serious conditions.12-14 For example, the FDA must find sufficient evidence of safety and effectiveness before it permits an expanded-access protocol involving large numbers of patients with serious disease. However, for individual patients, a physician only needs to conclude that the experimental drug does not pose a greater risk than the disease itself.12"
but:

Quote: "Effective expanded-access programs require the active participation of treating physicians. Some may be unaware of particular investigational drugs or unfamiliar with the process of obtaining them.34 Physician-directed expanded-access requests are infrequent.10 One explanation may be the difficult situation facing a physician who is considering an expanded-access request: regulations require that the physician determine that the risks of the disease outweigh the risks of the drug, but there is usually little published literature relating to the drugs at issue. The clinical information that manufacturers submit to the FDA is proprietary and, thus, available only to the extent that manufacturers permit.10

Physicians may also be reluctant to shoulder the administrative burden, since it takes approximately 8 hours for a physician to prepare an individual patient request.10 Federal regulations require obtaining appropriate informed consent and approval from institutional review boards, maintaining accurate case histories and drug-disposition records, and reporting adverse events.11 The FDA considers the use of expedited procedures with respect to institutional review boards inappropriate for expanded access,10 and full reviews can be costly. Many academic centers charge $2,000 to $3,500 for a protocol review, although fee-waiver requests in these settings may be available.35,36 For clinicians outside academic medical centers, locating and obtaining review by an institutional review board can be even more challenging.27"

Wolfgang (Germany)
MisterBlues
0
PR last night and is posted below several times but here is content:
CytoDyn to Hold Webcast on January 6 to Provide Timelines for Clinical and Regulatory Developments, Submission of 4 HIV BLAs and EUA Requests for COVID in Different Countries
1:35 am ET December 30, 2020 (Globe Newswire) Print
CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix(TM) (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 Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer, will host an investment community webcast on Wednesday, January 6, 2021.

Management will provide an update on recent clinical and regulatory developments regarding COVID-19 clinical trials, along with other strategic priorities:

1) BLA submissions to Health Canada, MHRA, EMA, and US FDA

2) HIV prevention trial/monotherapy trial

3) Potential revenue from HIV and manufacturing forecast

4) HIV Cure - amfAR

5) EUA submission timelines to same four agencies for COVID-19

6) Long-hauler clinical trial and potential data readout timelines

7) NASH trial and potential interim analysis timeline

8) Cancer trial Breakthrough Therapy designation potential timelines

9) GvHD trial status

10) Stroke/MS new trials in 2021

11) NASDAQ uplisting status

Management will also provide approximately 30-45 minutes to address questions submitted online by analysts and investors.

Date: Wednesday, January 6, 2021
Dappie
0
FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients
Download as PDFDecember 30, 2020 11:38pm EST
The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization

VANCOUVER, Washington, Dec. 30, 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 the U.S. Food and Drug Administration (“FDA”) has accepted the protocol submitted on December 28 for adding an open-label extension to its Phase 3 trial (“CD12”). Hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab. Treatment for eligible patients will continue until further notified by the FDA and/or CytoDyn.

The FDA also provided specific guidance for the benefit of physicians seeking access to leronlimab under an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study. The agency specified certain subgroups of patients will be excluded from the eIND authorization process: mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg and on vasopressors >48 hours.

Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We appreciate the specificity of the guidance from the FDA, as this will facilitate a prompt and efficient review and approval process for qualified patients. As the pace of this pandemic is not slowing down in the foreseeable future, providing a safe and effective treatment is the highest priority for all.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are most thankful to the FDA for their acceptance of the open-label extension to allow access to leronlimab for eligible patients and the definitive criteria provided for the benefit of physicians considering an eIND for their COVID-19 patients.”
Dappie
0
en nog: research paper aanvaard en wordt binnenkort gepubliceerd in medisch vakblad. Vier personen die onder eIND behandeld werden met leronlimab die volledig herstelden, al overleden 2 personen daarvan later. "Subcutaneous administration of leronlimab was safe and may have
been associated with remarkable recoveries in the four critically ill patients with SARS-CoV-2
infection, two of whom went on to be discharged from hospital while the other two died of
surgical complications after their initial recovery from SARS-CoV-2 infection".



CytoDyn Announces Research on Critically Ill COVID-19 Patients Published in Journal of Translational Autoimmunity
Download as PDFDecember 31, 2020 12:48am EST
Manuscript entitled: “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab,” by Nicholas J. Agresti, M.D.

VANCOUVER, Washington, Dec. 30, 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 a research manuscript submitted by Nicholas J. Agresti, M.D. has been accepted for publication in the Journal of Translational Autoimmunity. Dr. Agresti’s research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND.

The manuscript Ms. No. JTAUTO-D-20-00043R1 is entitled “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab.” The research paper can be accessed here.

Nicholas J. Agresti, M.D., stated, “We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are appreciative of Dr. Agresti’s work and view his publication as a validation of leronlimab as an important potential therapeutic in the treatment of seriously ill COVID-19 patients. Dr. Agresti’s four patients were treated with leronlimab under eIND. All four patients were on mechanical ventilator and they fully recovered.”
Dappie
0
Nabeurs conference call
REMINDER: CytoDyn to Hold Webcast on January 6 to Provide Timelines for Clinical and Regulatory Developments, Submission of 4 HIV BLAs and EUA Requests for COVID in Different Countries

Download as PDFJanuary 04, 2021 6:00am EST
Correction to inclusion/exclusion criteria for eIND authorization

VANCOUVER, Washington, Jan. 04, 2021 (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 Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer, will host an investment community webcast on Wednesday, January 6, 2021.

Management will provide an update on recent clinical and regulatory developments regarding COVID-19 clinical trials, along with other strategic priorities:

1) BLA/MAA submissions to Health Canada, MHRA, EMA, and US FDA
2) HIV prevention trial/monotherapy trial
3) Potential revenue from HIV and manufacturing forecast
4) HIV Cure - amfAR
5) EUA submission timelines to same four agencies for COVID-19, if CD12 Trial results are supportive of an EUA
6) Long-hauler clinical trial and potential data readout timelines
7) NASH trial and potential interim analysis timeline
8) Cancer trial Breakthrough Therapy designation potential timelines
9) GvHD trial status
10) Stroke/MS new trials in 2021
11) NASDAQ uplisting status

Management will also provide approximately 30-45 minutes to address questions submitted online by analysts and investors.

Date: Wednesday, January 6, 2021
Time: 1:00 pm PT / 4:00 pm ET
Sub!et
0

On December 15, 2020, CytoDyn reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. Analysis on this 390-patient data began on January 12, 2021, with expected results to be announced soon.

en.m.wikipedia.org/wiki/PRO_140
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