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Heeft CytoDyn het ultieme anti-HIV-middel??

1. [verwijderd] 18 oktober 2020 09:19

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   MisterBlues schreef op 17 oktober 2020 11:55:

   Er is al helemaal geen samenzwering van BP.

   Keep on dreaming. PB gaat echt opnieuw HIV vertragen. Dat en de trage S/C studie zijn tenminste de redenen dat ik mijn positie heb afgebouwd.
   
   En inderdaad, heel sneu voor al die mensen die op hogere koersen hebben gekocht. Die gaan naar verwachting heel veel geld verliezen de komende weken. Dr. Bruce Patterson staat nog steeds achter Leronlimab, dat is het probleem niet...
   
   En betreffende de gemiddelde aankoopprijs, met de winst kan gff een tig keer zo grote positie kopen op een gak van nul als de koers weer onder de $1 staat.
   
   fc
2. MisterBlues 20 oktober 2020 13:13

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   CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
   
   October 20, 2020 6:00am EDT
   
   DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint
   
   DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days
   
   VANCOUVER, Washington, Oct. 20, 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 recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.
   
   The DSMC had three recommendations to consider following its review of the interim analysis:
   
   Stop the trial due to safety concerns;
   Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or
   Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.
   
   The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.
   
   CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
   
   CytoDyn’s President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.
   
   During today’s webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic for COVID-19 and all of the opportunities that could be available to us in the coming months.” Dr. Pourhassan added, “We look forward to providing additional information during today’s webcast.”
   
   About Coronavirus Disease 2019
   CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/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 was conducted mid-October.
3. MisterBlues 20 oktober 2020 13:15

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   Kort samengevat inzake CD12:
   
   CytoDyn study of leronlimab for COVID-19 passes first safety review
   Oct. 20, 2020 6:52 AM ET|About: CytoDyn Inc. (CYDY)|By: Douglas W. House, SA News Editor
   
   The independent Data Safety Monitoring Committee (DSMC) has completed its first interim analysis of a Phase 2b/3 clinical trial evaluating CytoDyn's (OTCQB:CYDY) leronlimab in severe-to-critical COVID-19 patients. The analysis was performed on data from the first 50% (n=195) of participants.
   
   The DSMC recommends that the study continue unchanged.
   
   The next safety review will be conducted when enrollment reaches 75% (n=293).
   
   Full enrollment (n=390) should be achieved before year-end.
   
4. MisterBlues 20 oktober 2020 13:24

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   Hier sluit ik me graag bij aan:
   
   The DSMC recommendation is what you would expect if the results were trending toward statistical significance quickly enough to warrant approval prior to study completion. This is hardly surprising to longs given the clinical usage history of incredibly positive results.
   
   Ze hebben geen enkele andere keuze dan doorgaan. Anders zou de koers snel in elkaar storten. Omdat Corona aanhoudt zou het halen van de PE relevant kunnen worden. Dat er meerdere medicijnen op de markt komen is gezien de omvang van de Pandemie niet gelijk een sof.
   
   Hopelijk is de BLA/HIV/700 mg straks op de rails.
   
   De conferentie wordt heel saai. Ik ga dan ook niet kijken.
5. MisterBlues 20 oktober 2020 14:03

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   Unrecognized Therapeutic That Takes Dying from COVID-19 Off the Table - 30,000 American Lives Hanging in Limbo
   
   
   Tue, 10/20/2020 - 03:58
   
   
   When the pandemic started the United States government sought to protect its citizens with travel bans. That quickly escalated to quarantines and contact tracing on those affected. Cruise ships were quarantined and passengers held in military bases. Once the community spread started there was a run on PPE and masks. At first Fauci said “there's no reason to walk around with a mask” many speculated he was worried about a shortage of masks for healthcare workers. A look back at that policy; what was he thinking! Novel antivirals like Gilead Science’s remdesevir which was used in China moved onto center stage using the logic that if it works on ebola maybe it will work on COVID-19. Then Italy and Iran exploded with new cases and deaths. Then came the lockdown coupled with a stimulus package. The government’s answer was flattening the curve. To prepare for the wave of infected, ventilators were ordered en mass. Without solid clinical trial results remdesivir won Emergency Use Approval(EUA). The country started to come out of lockdown and the primary plan to deal with the virus was to develop a vaccine as quickly as possible and have Operation Warp Speed (OWS) ensure a ready supply of the most promising treatments upon approval.
   Early Convincing Therapeutic Evidence - IGNORED
   Not once did the government, key opinion leaders, or the media ask if there is a safe drug that could be repurposed for COVID-19 that takes people off the ventilators, gets them out of the hospital quicker, and is easy to administer. Before OWS was founded on May 15th 2020 here is a timeline of a therapeutic that was ignored by almost everyone.
   
   March 15th - FDA grants Emergency IND’s for 2 critically ill COVID-19 patients
   March 27th - Seven severe COVID-19 patients demonstrate promise and 2 are extubated
   March 31st - FDA clears phase 2 clinical trial of Mild to Moderate COVID -19 patients
   April 1st - FDA clears phase 3 clinical trial of Severely Ill COVID-19 patients
   April 7th - Phase 2 trial of Mild to Moderate COVID-19 patients starts
   April 13th - 5 Emergency IND Patients Discharged after leronlimab treatment
   April 15th - Phase 2b/3 trial of Severe to Critical COVID-19 patients starts
   May 4th - 54 Emergency IND’s for Leronlimab - Compassionate Use requested
   
   www.zerohedge.com/news/2020-10-20/unr...
   
6. MisterBlues 20 oktober 2020 15:01

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   quote:

   MisterBlues schreef op 20 oktober 2020 13:15:

   Kort samengevat inzake CD12:
   
   CytoDyn study of leronlimab for COVID-19 passes first safety review
   Oct. 20, 2020 6:52 AM ET|About: CytoDyn Inc. (CYDY)|By: Douglas W. House, SA News Editor
   
   The independent Data Safety Monitoring Committee (DSMC) has completed its first interim analysis of a Phase 2b/3 clinical trial evaluating CytoDyn's (OTCQB:CYDY) leronlimab in severe-to-critical COVID-19 patients. The analysis was performed on data from the first 50% (n=195) of participants.
   
   The DSMC recommends that the study continue unchanged.
   
   The next safety review will be conducted when enrollment reaches 75% (n=293).
   
   Full enrollment (n=390) should be achieved before year-end.
   
   

   CD12
   
   All you need to know.
   
   - Recommend trial to continue
   - Interim analysis at 293, current enrollment at 230
   - UK sites should be online in days
   - Expect full enrollment of 395 by year end
   - Adjust mortality endpoint to 42 days
   - CYDY seeking ongoing guidance from the U.S. FDA and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.
   
   The money is in the long hauler population. The 42 day endpoint provides extra data for this group.
   
   The fact that there are no modifications AND that the DSMC appears to see even greater statistical strength at 42 days is very encouraging.
   
7. MisterBlues 20 oktober 2020 17:35

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   Below: exactly what you will here today:
   
   Some people here asked why CYDY does not unblind the data. YES, they could, but why would they commit suicide ??
   
   From the DMSC Recommendations it is now very clear: this trial is not only on track, but the data are even better than expected. For that reason the DMSC expects that there is a good chance to do another interim analyses with 275 patients (75 % of the number of what was originally planned, i.e. 390).
   
   That means: at present the the p-value for the primary endpoint is yet somehow higher then the required 0.05. DMSC proposed another early interim analyses with 275 patients because they do not want to miss and lose the time if the p value dropped below 0.05 with already 275 patients, by continuing until 390 patients.
   
   I have assessed several hundred trials of small and big pharma, biotechs and classical pharma companies. The above is the only possibility now. There are no other applicable hypothesis anymore. Leronlimab works with reduction of mortality somewhere between 40 and 50 % .
   
   So why does CYDY not unblind the data to show that ? People here still do not understand clinical trials and their statistics. If CYDY would now unblind the data and the mortality reduction is about 45 %, but the p value is about 0.07 - this trial would be IRREVERSIBLY WASTED and SPOILED. FDA would refuse it for any further considerations.....
   
   For that reason CYDY has NO OTHER CHOICE than continuing, speed up enrolling and await the next interim analysis with 275 patients.
   
   FDA is the one who has no the options: to grant EUA on the basis of a trial that despite strong reduction of mortality is not yet statistically significant or to wait until the 275 patients. If looking to this trial in isolation, I as a regulator would NOT grant EUA as long as the statistical significance is not shown. That is the nature of statistics - it still can be a by chance finding. Yes, a 40-50 % is still a by chance finding if you have not yet recruited a statistical significant number of patients. However, regulators (in EU and US) normally do not look to a trial in isolation, but consider all data. And here FDA now has a margin - by taking into account also the CD10 results, the IND patients and the mode of action. FDA COULD grant EUA - not sure if they are brave enough....
   
   My best guess now is: this trial MUST continue for the sake of all future critical/severe Covid patients ! it will speed up now with the very encouraging and positive recommendations from the DSMC.
   
   Only those who do not know how clinical studies and their statistics work - they may not follow, but leronlimab is very well on track.
   
   You will here EXACT the above today - because there is no other interpretation (than that leronlimab works better than expected) and there is no other option for Cytodyn than to continue now until 275 patients!
   
   Reactie:
   I'm in 100% agreement on NOT unblinding the study, as it would be a total waste.
   
   However, where I disagree with you, is on your assessment of not awarding an EUA. The FDA uses a lowered bar where safety is paramount, and the drug only needs to show that it MAY BE effective (with quantitative data to support the claim). That's per Dr. Hahn at the FDA. This is a much lower bar than what you are holding to. As such, Leronlimab IS safe AND there is enough statistical data to support that it would reach its primary endpoint at 75% of the original planned protocol. Therefore, it may indeed be effective. The 2 conditions for EUA are, thus, satisfied.
   
8. MisterBlues 20 oktober 2020 23:52

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   Precies wat ik dacht: gewoon doorzetten van CD12 tot 275 patiënten.
   
   Samenvatting conf.:
   
   Summary of discussion before Q&A:
   
   NP:
   • COVID overall update in USA. Must show reduced mortality in S/C trial. Shared anecdotal data of pt survivals with LL. 60 eIND apps approved leading to S/C trial. LL indicates continuously positive forward progress. Great news – Positive DSMC recommendation to continue study as planned to achieve primary endpoints. No need to change study. Added that would like to see interim data at 75% pt mark (293 – magic number). We need 63 more patients. 16 hospitals enrolling, 7 pending.
   • Received positive news about publication and will be sent to MHRA now.
   Dr. Jacob Lalezari
   • Started a twitter account. Tweeted to get LL approved.
   • FDA – no value to eIND data. CD10 results they claimed as getting lucky. CD12 data is the important info
   • DSMC meeting – Asked about adjusting dosing, maybe 3 or 4 doses of LL. Response was to not change trial design and continue to hit primary endpoint. Asking for only 75% enrollment and want another look at data.
   • He’s anxious and hopes the study was over right now. All signs point to LL success in COVID-19. No data point saying the drug doesn’t work
   • Another analysis at 293. Enrollment has been difficult (GILD taking up so much space). However, SOC remdesivir has proven useless. Hopefully becomes easier to enroll. “As close as we can be to the finish line”.
   Dr. Scott Kelly
   • HCQ – failed IL6 inhibs – failed. Eli Lilly’s MAB cocktailed – paused. CYDY trial – continuing.
   • CYDY – potential leader in COVID-19. Hoping that hospitals will be encouraged to enroll now with DSMC recommendations
   NP – slideshow
   • HIV –
   o Talking to MHRA in 6 days for BLA.
   o Meeting with Health Canada on Nov. 9
   o Meeting with EU
   o Filing in USA at “end of year”. Hired another person to handle this. Being announced tomorrow in PR. No more dragging our feet with other indications
   • COVID-19
   o How fast can we enroll? We need more data (remdesivir had thousands of pts).
   o CD10 – not moving quickly and not a priority. Hoping for CD12 S/C approval. Longhaulers are a priority.
   o Cancer – dragging feet and very slow
   Trying to enroll very quickly
   2 more people bought onto team
   12 patients enrolled
   
   o GvHD (Graft vs Host Disease)
   Only need 5 more patients
   o NASH -Dr. Kelly
   Using new imaging tech.
   Made changes to inclusion/exclusion to improve enrollment
   1st pt visit in November
   o MS/Stroke
   Protocol and IND submission
   
   • Manufacturing
   o Samsung Biologics – receiving 300,000 vials this month
   
   • Publication from Dr. Otto Yang
   • Looking to submit several other publications
   o As soon as next week for 1 publication
9. MisterBlues 21 oktober 2020 17:20

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   Cydy bedreigingen en kansen
   
   Waar ze het gisteren niet over hadden is dat een nieuwe emissie onvermijdelijk is - gezien de vele onkosten van de onderzoeken én last but not least de onkosten voor een voorraad aanleggen van Leronlimab in geval van vroegtijdig succes. Ten onrechte zo blijkt. Toch hoeft Cydy niet helemaal weer terug bij af te gaan en door het putje te kruipen...
   
   Hier nog de sterke punten van gisteren.
   
   Yesterday was a momentous day in CYDYs history, so much happened. Here is a quick recap for newbies.
   
   1. 6qm PR DMSC positive review. Another interim review at 290, add endpoint of 42 days. Statisitcal significance likely to occur at that point (imho).
   
   [b]2. Peer reviewed PAPER released. The great Dr. Yang from UCLA lead author. Oxford Press! No more criticism.[/b]
   
   Nu maar hopen dat Dr. Yang geen aandelen heeft of anderszins belang...Wel even onderzoeken natuurlijk
   
   3. NP makes another new, strong appearance on Fox Business 4:45PM, reason for delay in CC.
   
   4. We learn the 5 UK hospitals should be online in a matter of days. This will make a total of 20 hospitals recruiting. Now that Remdesivir is proving to be a fail in stopping mortality, enrollment may accelerate. Teams will be put in place to help push enrollment. Target of 60 by December.
   
   5. We learn CYDY has hired a ringer to help with the HIV BLA application. Meeting with MHRA in UK in 6 days for pre BLA HIV meeting.
   
   Deze is ook erg belangrijk. Het zou tijd worden dat ze er extra aandacht aan besteden.
   
   6. We learn CYDY has hired a Chief Scientific Officer with deep experienced with BigPharma and UPenn. Very experienced person. Shareholders should be happy
   
   7. We learn that a new PR firm has been hired to assist with well PR.
   
   8. Protocol for Phase 3 moderate trial should be done end of next week.
   
   9. New format for Webcast.
   
   10. Dr. Kelly throws some shade on CCR5 by talking about inflammation markers and how inflammation is at the root of so many ailments. We need more science discussion.
   
   11. I made contact with WSJ author of yesterday's article on Doctors with Long Haulers. She is going to follow up with Dr. Recknor.
   
   
10. MisterBlues 22 oktober 2020 08:51

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    quote:

    MisterBlues schreef op 21 oktober 2020 17:20:

    Cydy bedreigingen en kansen
    
    6. We learn CYDY has hired a Chief Scientific Officer with deep experienced with BigPharma and UPenn. Very experienced person. Shareholders should be happy
    
    

    Toe maar. Alsof het allemaal niets kost. Als dit betekent dat de BLA per 31 oktober voor HIV / 700 mg op de rails staat is dat natuurlijk in meerdere opzichten baanbrekend.
    
    CytoDyn Appoints Mahboob Rahman, M.D., Ph.D., as Chief Scientific Officer
    Download as PDF
    October 21, 2020 5:42pm EDT
    
    Dr. Rahman’s 18 years of pharmaceutical industry experience is highlighted by 16 successful BLA/NDAs and sBLAs
    
    VANCOUVER, Washington, Oct. 21, 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 appointment of Mahboob U. Rahman, M.D., Ph.D., FACR, to the executive position of Chief Scientific Officer.
    
    Dr. Rahman was most recently Global Head of Immunology Development and Pharmacovigilance at Mesoblast Inc. (ASX: MSB; Nasdaq: MESO), a global leader in allogenic cellular medicines for inflammatory diseases.
    
    
11. MisterBlues 22 oktober 2020 09:49

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    Ik ben benieuwd naar het waarheidsgehalte van deze post...
    
    RLFTF is set to gain from CYDY which is in deep trouble and yesterday's hype will wane and reality will set in. They are 60-90 days away from possible approval. Once they realize this they will be flocking over to Relief. Many are already invested in both and will shift their holdings over to the brighter more promising therapeutic.
    
    RLF-100 by Relief Theraputics has awesome EIND results, P3 readout in next 10-14 days with likely very significant results, and EUA already applied and waiting at FDA. Note their EIND results were WAY better than CYDY. In fact their EIND results were statistically significant at p<.0001 level compared to placebo for a small 24 sample.
    
    www.pmlive.com/pharma_news/relief_the...
    
    Plus they control their space with exclusivity for their drug vs fighting with Pfizer that CYDY now faces in their competitive drug Maraviroc, which is also a CCR5 modulator, but is already approved for HIV, and costs $12 per pill vs CYDY 2k-4K per shot (and no side effects for a short course, so save that argument, it’s more Nader spin than fact and Pfizer is proving it in their P3 CV19 trial).
    
    For the sake of the World I hope we get a therapy out to patients, but I’m fairly confident CYDY will NOT be the first therapeutic to treat severe CV19 patients.
12. MisterBlues 22 oktober 2020 18:08

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    Dr. Yang's Oxford published analysis on the 23 severely sick patients with significant co-morbidities and an average age of 70. From the report:
    
    "Co-morbidities were wide-ranging, most commonly hypertension (13/23), chronic kidney disease (8/23), and type 2 diabetes mellitus (5/23), Others included organ transplantation (heart=2/23, liver=2/23,
    kidney=1/23), malignancy (breast=1/23, lymphoma=1/23), vascular disease (heart=1/23,
    carotid=1/23), COPD (2/23), pulmonary fibrosis (1/23), and rheumatologic/immunologic
    disorders (Sweet Syndrome=1/23, rheumatoid arthritis 1/23). Overall this was a high risk
    cohort with significant co-morbidities."
    
    17 of these 23 who had already tried other medicines such as Remdesivir, HCQ, open label tocilizumab, and convalescent plasma... ALL of these had failed those patients.... yet LeronLimab is what got them off the oxygen machines and allowed them fully recover. 4 had died and 2 were still hospitalized after the 30 day assessment period.... 17 of 23 after being first administered LL at 9 days (after the other above mentioned procedures had failed) .... this drug is quite literally a miracle.
    
    "Overall, our findings suggest a benefit to leronlimab in the treatment of severe COVID-19,
    including persons requiring mechanical ventilation. Some routine clinical markers of disease
    severity (blood CRP, D-dimer, and neutrophil:lymphocyte ratio) were associated with
    outcome after leronlimab treatment while others were not (ferritin, lymphocyte count,
    monocyte count, LDH). Whether this is due to our small cohort size or differences between
    leronlimab treated versus untreated patients is unclear. Randomized placebo-controlled trials
    are now underway and should help provide more helpful data to clarify efficacy and
    predictors of response to leronlimab to treat COVID-19."
    
    "The data provide anecdotal evidence for a benefit from treatment. Most of our
    patients had significant risk factors for severe disease, including age over 60 and comorbidities associated with poor outcome [17, 18]. Of the 23, seven required mechanical
    ventilation at the time of leronlimab dosing. Of these critically ill patients, six of seven were
    alive after >70 days, a substantially higher survival rate than other reports of critically ill
    COVID-19 patients [19-22], which range from 42% to 61% in cohorts followed about 30
    days after hospitalization. Of the 15 with milder (but still “severe” as defined by
    supplemental oxygen requirement) illness, 13 no longer required further acute hospital care
    by 30 days. Thus, the overall outcomes for this high-risk group of patients was better than
    historically observed in multiple reports from the same time frame"
    
    
13. MisterBlues 24 oktober 2020 09:25

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    De prestaties van CEO Nader P. - Zeldzaam slecht:
    
    you've burned through millions without acquiring any new funding. You've had the CEO promise trials in 3 countries that have failed to materialize. You've had the BLA rejected and admission that it will not be ready for at least 6 months. You've had the CEO mislead you into thinking he submitted an EUA application when he hadn't. You missed all but one endpoint in a phase 2 trial. And you didn't have your phase 3 trial suggesting he oversold the eIND results. Anything else you want listed you idiot? Uplisting Nasdaq?
14. MisterBlues 24 oktober 2020 09:35

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    akeaways on Proactive Video today.
    1. Longhaulers - Protocol filing should be finished next week. Confident they can fill the trial this year. Only company known to have a treatment for this. 75% of hospitalized patients suffer from LH symptoms.
    2. FDA can look at the unblinded data if they want. CYDY can't say if this has happened or not. Will report if this happens.
    3. Hints at another national coverage event ahead!
    4. Monday 10/26 meeting with MHRA to file BLA for HiV.
15. MisterBlues 27 oktober 2020 08:33

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    @FC,
    
    Cydy gaat niet onder de 1 komen zoals ik al aangaf - HIV BLA (UK en/of USA) was zeer nabij. Ze waren te dicht bij - hier en daar - een succesje, nu gaat de fantasie der beleggers de rest doen. Ondanks de geldverspilling van de vele onderzoeken die allemaal nog lopen, overigens! Onder 1 gaan we niet, dus jullie zijn je goede GAK kwijt. Ik denk echter dat jullie nog een plukje hebben laten staan omdat jullie het ook niet zeker wisten. :)
    
    Ik heb gezien dat je een post voor me had. Deze ga ik nog uitgebreid beantwoorden - of je het nou wilt of niet. Thema: lijdt Cydy nou vooral onder BP of door een eigen onhandig beleid?
    
    Persbericht
    
    U.K. MHRA Clears CytoDyn to File its BLA for Leronlimab as One Injection per Week for Combination HIV Therapy
    
    October 27, 2020 12:00am EDT
    
    VANCOUVER, Washington, Oct. 26, 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 has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in the U.K.
16. Fortuno 27 oktober 2020 14:13

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    Grote lantaarn, klein licht.
17. MisterBlues 28 oktober 2020 10:45

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    quote:

    greedfearfear schreef op 27 oktober 2020 14:13:

    Grote lantaarn, klein licht.
    

    Jij hebt nog nooit gelijk gehad op dit forum. Om maar eens wat te noemen:
    
    1,5 maand terug zou 4 dollar nog een goede instapprijs zijn.
    
    2 maanden terug zou uplisting er komen.
    
    Van alles is documentatie op dit forum. Nog meer ook!
    
    Nu heb je verkocht en je denkt dat de mensen die na jou komen het aandeel uitkotsen als ze ook verkopen? Is daar niet wat 'ongerijmd' in? Self fulfilling prophecies?
    
    Wispelturig als een zwevende zak in de wind. Een kind die denkt dat ie beter is dan een ander. Gewoon een scheldpartij? Kan je niet beter?
18. MisterBlues 30 oktober 2020 08:34

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    Ik ben benieuwd of de UK trial al begonnen is…?
    
    UK Marketing Authorization Holder Information:
    Its interesting in the UK clinical trial info,
    www.clinicaltrialsregister.eu/ctr-sea...
    they already mention the company that will be doing the packaging/distribution of Leronlimab
    On line D.2.1.1.2, it says: that the “Name of the Marketing Authorisation holder,” is:
    “SHARP CLINICAL SERVICES (UK) LIMITED.”
    Sounds like this may be further along than the company has publically released information.
    
    I also note that the trial info states that the 'Investigational Medicinal Product has a Marketing Authorisation in the Member State concerned by this application.' (in D.2.1). I think the MAA (Marketing Authorisation Application) is the UK equivalent to a NDA in the FDA (New Drug Application). So I'm interpreting this as a successful trial result could lead quickly to full approval in the UK?
    
    Also, in section E.8.9, it states the UK trial is estimated to be 2 months long. Fairly quick.
    
19. nb 1 november 2020 12:25

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    Bedankt MB, voor je niet aflatende post. Ik houd een (zeer) klein bedrag aan in Cyto, puur voor mijn nieuwsgierigheid. Zo doe ik dat in meerdere bio, waarvan er enthousiaste post is en er kansen zijn, bv trials in fase 2 of 3. Of soms, zoals in Miragen, kans op succes in verkoop/uitbreiding markt. Rijk wordt ik er niet van, nog...:)
    Ik moet zeggen, geen idee of Cyto iets kan gaan doen, ik kan me er ook niet druk om maken, zou me teveel tijd kosten, ik heb een meer dan fulltime baan, en dat levert meer op momenteel.
    Nogmaals bedankt voor jou inspanningen.
20. MisterBlues 1 november 2020 15:04

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    quote:

    nb schreef op 1 november 2020 12:25:

    Bedankt MB, voor je niet aflatende post. Ik houd een (zeer) klein bedrag aan in Cyto, puur voor mijn nieuwsgierigheid. Zo doe ik dat in meerdere bio, waarvan er enthousiaste post is en er kansen zijn, bv trials in fase 2 of 3. Of soms, zoals in Miragen, kans op succes in verkoop/uitbreiding markt. Rijk wordt ik er niet van, nog...:)
    Ik moet zeggen, geen idee of Cyto iets kan gaan doen, ik kan me er ook niet druk om maken, zou me teveel tijd kosten, ik heb een meer dan fulltime baan, en dat levert meer op momenteel.
    Nogmaals bedankt voor jou inspanningen.
    

    Tja, ik heb ook veel pech gehad dit jaar wat betreft Biotech. (Veel mensen natuurlijk.) Galapagos filgotinib dat werd afgekeurd door de FDA, Mithra dat lijdt onder de vertraging als gevolg van Corona. Gelukkig compenseren mijn winsten bij BioNtech en Relief dit met gemak en met geduld komt het goed met de eerste 2 genoemden.
    
    Over geduld gesproken: we zijn behoorlijk beproefd door Cydy. Gelukkig had ik het - voorlopig - uitblijven van succes zien aankomen en zit ik er niet meer dik in. Toch zit er veel tijd in en het blijft fascinerend of het medicijn nu echt (te) goed is voor deze wereld of niet, en of het echt actief wordt tegengewerkt zoals sommigen beweren. Ook de financiën zijn (nog) schimmig(er) geworden.
    
    Ik ga daar een langer stuk over schrijven en ga dat met enig plezier doen. Leuk als dat her en der opgepikt wordt zoals door jou. Ik heb door Corona iets minder werk en ben eigenlijk niet meer van de beurs en de ontwikkeling van aandelen weg te slaan. Het vult op een leuke manier een gat in de tijd en nu wil ik ook zien dat werkende therapieën en (half)werkende vaccins de markt bereiken.
    
    Omdat ik in bepaalde aandelen zit die de potentie hebben oplossingen aan te reiken voor de pandemie leef ik intens mee met de wereld.