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CYDY CytoDyn Inc

Mod: mightycydy Asst: HHIGambler,CaptnAmerca
Last Post: 12:05 PM
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CYDY Stock Quote & Tools

$0.1980 ▼ -0.0020 (-1.00%) As of Oct 7, 12:38 PM EDT
Last0.1980
$ Chg-0.0020
Open0.1989
High0.2020
Beta1.4964
Year High0.397
Market Cap290.96M
P/B Ratio-2.68
EPS-0.03
Avg Vol (30d)1.60M
Volume1.32M
% Chg-1.00%
Prev Close0.2000
Low0.1976
VWAP0.19993
Year Low0.183
Total Shares1.47B
Shares Out1.47B
Float1.36B
ExchangeOTCQB
Healthcare Biotechnology & Life Sciences
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CYDY Stock Message Board Discussion

3 Pinned Posts
Leronlimab (Pro 140) Cliff Notes What is it? Leronlimab is a humanized monoclo (43) by trding
Leronlimab Regulator List (a work in progress) = upregulation = downregulation a-SMA (21) by ohm20
EIND: Information to Submit to Doctors Leronlimab a humanized monoclonal antibody binds CCR5, (38) by ohm20
  1. invisioner

    I agree with everything you said, but I believe the DMSC may have consulted with the FDA per the

  2. ClosetInvestor

    Based on the guidance provided by the DSMC, will Cytodyn request from the FDA either an

    (2)
  3. CDiddy

    293rd by beginning of November is not likely. We need to skip the "bonus" interim analysis and

    (3)
  4. ohm20

    Neither the DSMC or FDA are going to assume it's only beneficial.

  5. ohm20

    A reply at ihub to Grip It and Sip It that's sure to disappear. I would say bankruptcy or

    (6)
  6. SAF

    How do people feel funding factors into this situation? The current balance sheet versus how long

    (1)
  7. lorbas

    Interesting. Thanks!

    (1)
  8. TechGuru

    This is a very interesting question. imo, we should be using a one-tailed test. Why??? The

    (2)
  9. ohm20

    If data was forwarded it would be a request for guidance from FDA on whether to submit an

  10. ohm20

    With 23% bioavailability for Maraviroc I wonder what receptor coverage will be at in 7 days. I know

    (2)
  11. mtruong34

    Cytodyn crew can't be that stupid to keep making the same ambiguous mistake over and over, so it

    (2)
  12. TechGuru

    So, this is the news we were expecting. Main takeaway: the DSCM has found out that

    (24)
  13. Bw

    I prefer it this way as far as eua ... No point in making that public unless granted as it may

  14. ClosetInvestor

    could mean that Amarex submitted data to the FDA on behalf of Cytodyn while still keeping it

  15. jk1550

    Interesting. Thanks

  16. jeff67

    This is solid news. Now the number 1 question for management will be: Based on the guidance

  17. CrazyRon

    For an EUA to be granted, doesnt Cydy have to apply for it first?

  18. lorbas

    To my knowledge e.g. the dexamethasone study used a two-tailed to. For one-sided p-value you

    (1)
  19. CaptnAmerca

    Release the unblinded data, and PR the whole thing. That should help speed enrollment and put the

    (6)
  20. JLang

    The odds of the FDA giving any input yet are small / unlikely... This is the Data and Safety

    (13)
  21. jk1550

    lorbas, why do we need a 2-tailled distribution? The left hand side is totally of no use to this

  22. dfwl28

    B Patterson PR. excerpt Maraviroc, an oral medication, will be administered for seven

    (1)
  23. Eyedr

    I thought I read something from the FDA's website that the number of interim analyses has to be

  24. lorbas

    https://www.prnewswire.com/news-releases/incelldx-to-study-maraviroc-a-ccr5-antagonist-in-a-covid-1

  25. ohm20

    That Cytodyn is "seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory

    (3)
  26. SAF

    I agree. At face value its hard to read the statement any other way. Definitely puts longs in

    (1)
  27. jk1550

    Blafarm, Please tell me what is really achieved if by chance we get the extra patients all enrolled

  28. Riztheinvestor

    Figured, good point.

  29. Riztheinvestor

    "If the DSMB reports that the clinical trial is likely to meet its endpoint and that they should

  30. CTMedic

    SAF, I believe you are 100% correct, that DSMC expects endpoint to be met, possibly at 75%

    (6)
  31. ohm20

    That EUA is based on risk/benefit analysis and leronlimab has an excellent safety profile and the

    (5)
  32. blafarm

    Odds will be high that none in the LLMab arm need a treatment past 14 days, imo... But it's

    (2)
  33. JLang

    Re: 42 day survival, with so many critical patients being in the ICU & on ventilators for > 20

    (1)
  34. Eyedr

    That's $3.24 USD +/- (2.74 euros) in case you don't have a conversion handy.

  35. Boatbuilder

    Pushes any positive news out to @ January 20th. Isnt that ironic.

    (2)
  36. generactor

    Ohm, do you think unblinding now would be a good idea given your post positing interim p-values

  37. invisioner

    So, they ARE changing the endpoint? It is confusing. It still says 28 days on clinicaltrials.gov.

  38. ohm20

    DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze

    (3)
  39. Eyedr

    https://www.bloomberg.com/quote/296:GR Up 15% on Stuttgart this morning. Woot,

  40. JLang

    Odds are that stat sig was met, but they're just shy of a p value justifying a halt... This is

    (1)
  41. lorbas

    Playing with some numbers for 75% enrollment... For n=294, Death Rate

  42. ohm20

    We should have at least 5 additional sites in the UK, 20 total. With 20 sites they would have to

    (1)
  43. blafarm

    Well, best case scenario might be enrollment in 4 weeks. That means the next interim enrollment

    (5)
  44. invisioner

    Wait, why 42? I am thinking 28. Where does the 42 come from?

  45. JLang

    Great summary of the issues and history of these failed CCR5 antagonists. But it isn't just CCR5

    (3)
  46. invisioner

    I totally agree with and also feel the frustration, but I don't think NP has a choice but to take

    (1)
  47. ohm20

    It's obviously 42 days after the 293rd patient is enrolled. The DSMC obviously thinks p value halt

    (8)
  48. invisioner

    And furthermore, if the trial was close to a p value to stop it, why did the FDA have it continue?

    (5)
  49. KenChowder

    Yes. Otherwise there would be no reason to add the additional interim.

  50. LaundryMoney

    I think because NP is not going to take this analysis lying down. If they are close enough that 293

    (4)

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