CYTODYN INC. DL -,01 WKN: A0YHA5 ISIN: US23283M1018 Kürzel: 296 Forum: Aktien Thema: Hauptdiskussion

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CytoDyn completes enrollment in Phase 3 trial for severe-to-critical COVID-19 https://seekingalpha.com/news/3644685

Komm Cytodyn, steige doch mal für Setko. ;-)

Here is my take on the Webcast: Covid: Philippines EUA appln - Cytodyn is planning on requesting a Covid EUA approval in the Philippines within a couple of weeks based upon the CD010 mild/moderate trial results. Cytodyn has consulted with Philippines FDA experts and was encourage to file because the pandemic is very bad there. Backstory is Philippines had said it was not granting any more EUAs but due to the accelerating infection rates, the President recently ordered that policy to be changed. The change is expected to take effect within a couple of weeks. US COVID approval – CD012 severe/mild trial 390 patient enrollment is accelerating much more quickly than expected and the 390 patient enrollment should be completed by this weekend. Word appears to be getting out about leronlimab. 28 days after enrollment completion, about January 4, they can gather, unblind the data and do the analysis for presentation to FDA. This will be quicker than the DSMC requested 293 interim look at 42 days so they are not going to bother doing the interim analysis. Based on this time schedule, presentation to FDA should be by the 1st or 2nd week of February. If the results are as good as all the prior clinical trials and eINDs indicated it is, an FDA EUA would issue forthwith. UK and Canada and Philippines would follow suit if they haven’t granted an EUA first. US Covid Long Hauler trial – Long Hauler symptoms include chronic fatigue and other things. 10% of the Covid the 70 million Covid patients, regardless of severity and including those with no Covid symptoms, or 7 million people are affected by Long Hauler symptoms. Cytodyn has proposed a trial to FDA and expect to address FDA’s final comments this week. Based on the scientific literature on the causes of Long Hauler symptoms, they are very optimistic that leronlimab will be effective in treating Long Hauler symptoms. Dr. Bruce Patterson, who is not affiliated with Cytodyn or doing any business with them at the moment, said he thought leronlimab would be effective in treating Long Haulers in a recent Webcast. Covid bottom line, could have Philippines EUA approval by the middle to late January. US EUA approval or maybe BLA, a week or two after that. Cytodyn will have 1.2 million vials of leronlimab by the end of this year and will charge the same price as Remdesivir which will net Cytodyn $2.5 billion. If Philippines approves leronlimab first, the Philippines will get the vials. Next year’s Covid revenue, assuming an EUA approval as discussed above is estimated at $5-10 billion. If the Long Hauler trial pans out, that will greatly expand the market. They are also looking at giving leronlimab along with the vaccines to increase efficacy and prevent hospitalization. After all if the CCR5 receptor is blocked before the virus replicates, then it can’t cause a cytokine storm. Medicare and Medicaid have already assigned a reimbursement code for leronlimab. Cytodyn has signed up Samsung to manufacture it and American Regent to distribute it. They are ready to monetize it. HIV • The BLA filing expert PhD, MD hired to take charge of the BLA filings said he has reviewed the data and that it is highly probable that HIV combo therapy BLA will be approved by FDA. He will give us a filing timeline soon for FDA, UK, Canada and possibly EU. • HIV monotherapy will be next for HIV. They have trial results to support it. • They will also do an HIV prevent trial to show leronlimab prevents sexual transmission of HIV. This was shown in a monkey study only so far. • They are working with an internationally recognized organization AMFAR to do a study to see if leronlimab can cure HIV in bone marrow transplant patients. There is a scientific basis to believe it can. HIV bottom line – HIV combo therapy has a high probability of being approved 6-8 months after filing the BLA. Cytodyn’s new BLA filing expert will shortly give us an idea when they expect to file. Label expansion to monotherapy and HIV transmittal prevention is expect to follow. They may also get approval for HIV bone marrow transplant cure if that pans out. HIV drug treatment market is currently about $30 billion. Cancer o Cytodyn has 8 patients in a solid tumor basket trial who have different types of cancer to see if they can last 6 months needed for approval. 3-4 of them are already at the 3-4 months mark. o A triple negative breast cancer patient has lasted 12 months o They are putting together a team to give more focus to cancer. Nash This is a fatty liver disease that has no effective treatment and affects a large segment of the population. It is the number 1 cause of liver transplants. People with this disease show high levels CCR5 and CCL5. Leronlimab moderates CCR5 expression. Leronlimab moderates CCR5 expression. Leronlimab has shown tremendous results in animal studies. It’s a $27.2 billion. Cytodyn has just signed up its first NASH trial patient.

Hier ein Auszug aus dem forum, der das nochmal alles gut wiedergibt

Darüber hinaus ist die Stimmung in den Foren recht positiv.

Das war doch klar, dass es keine Zulassung gibt.... Wie auch.... Wichtig ist doch das die Prozesse stimmen und positiv verlaufen. Mit der Zulassung darf man nächstes Jahr rechnen.

Aber leider immer noch keine Zulassung 😏

Patienten Rekrutierung in ca.1 Woche abgeschlossen 👍Updates wie erwartet 😏.Jetzt warten wir mal das enrolling ab, es bleibt spannend 😉

Ist das jetzt alles positiv aufzufassen oder negativ ?🤔

CD-12 update: -371 patients -5-6 patients a day enrolling -had a record 15 patients enrolled in a single day -should be finished by this weekend -because enrollment is so fast, there will be no interim analysis long-hauler trial update: -expect "incredible" data -will do interim analysis after 60 (?) patients -close to submitting final comments for approval to proceed -expect 7m patients for this indication, including younger patients -identified long-hauler MOA EUA for Philippines: -not filed yet -hope to file in a couple weeks with CD10 data (and maybe blinded CD12 data) NASH update: -new partnership with a UK diagnostic company for NASH -believe that we can address both NASH and fatty liver disease Cancer update: -5 colon cancer patients (1 deceased) -2 prostate cancer patients -5 breast cancer patients -8 patients are at least 4 months along -hired new oncologist HIV update: -may file with EU (in addition to US, UK, and Canada) -received detailed feedback on application -high probability of success HIV cure: -developing protocol for trial Vyrologix once-a-month treatment: -strong potential for once-a-month treatment for prep NASDAQ update: -application is on hold (not rejected) -still dealing with equity requirement and stock price requirement (and tangible assets

Bin gespannt was gleich als news kommt, hoffentlich mal was richtig gutes . Hört jemand irgendwo mit ?

Danke schön

Nach Handelsschluss, ab 22 Uhr hiesiger Zeit, man kann den Webcast über die Website verfolgen.

Ab wann wird es morgen spannend , habt ihr eine Uhrzeit ? Nicht das ich hier morgen groß warte und die news kommen erst wieder nachbörslich nachts oder so

Sehr schön STS2011 . Hier mal der Abschnitt zu Cytodyn: CYDY hingegen scheint viel mehr zu bieten. Zunächst einmal ist es in Bezug auf GvHD ein besseres Medikament als CD24Fc, basierend auf seiner theoretischen MOA in COVID-19. Bei ALLEN COVID-19-Patienten, die Leronlimab einnehmen, ist der Zytokinsturm in 3 Tagen beruhigt. Dies ist eine beeindruckende Leistung, aber darüber hinaus scheint Leronlimab auf dem richtigen Weg zu sein, um seinen Endpunkt für die Sterblichkeit zu erreichen. Viele Investoren erwarten, dass die schwere bis kritische klinische Studie in den nächsten Wochen abgeschlossen sein wird. Dies könnte ein wichtiger Katalysator sein, da Investoren aus Angst, einen außer Kontrolle geratenen Güterzug zu verpassen, der möglicherweise nicht nur das nächste Medikament ist, das EUA erhält, sondern alle die volle Genehmigung für das Inverkehrbringen erhalten, in diesen Namen zurückkehren. CYDY hat eine rollierende BLA und ist daher durchaus genehmigungsfähig. Der CEO von CytoDyn hatte angegeben, dass der Umsatz von COVID-19 im nächsten Jahr 7 Milliarden US-Dollar übersteigen könnte. Basierend auf dem 1-fachen COVID-Umsatz, der sich auf einen Aktienkurs von 12,00 USD + beläuft und kurzfristig eine 5-fache Rendite darstellt. CYDY ist ziemlich unterbewertet und sollte angesichts der sehr starken Korrelation von EUA-zugelassenen Arzneimitteln, die es auf diese Liste schaffen, aggressiv gekauft werden, um das Aktionärs-Update durchzuführen.