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We don't know the breakdown from the PR since it is only declaring results for the critically-ill subset. We will have to wait until Monday for total deaths, endpoints met/unmet, etc.
My bad...you're right. There is no way to reverse calculate.
The p-value for the CD12 primary endpoint was probably around .072. Given that .05 is an arbitrary number, I still think this is a great result. I'm reverse calculating the following:
Total deaths: 88
Placebo MR: 26.7% (35 deaths/131 pop.)
LL MR: 20.2% (53 deaths/263 pop.)
LL performed consistently as it did at the interim. Mortality rate in the placebo arm was just significantly lower than many including myself were factoring.
All IMO.
Probably same gag order. Even though we've been talking on this board for over year about the two-fold problem of Covid-19 (the virological and the immunological response), the FDA only recently seems to have put two and two together.
The FDA now needs to craft a new public message - "At first our goal was to attack the virus head on, but new data show without question that the immunological response to Covid-19 can be equally deadly and is most likely responsible for PASC (i.e. the new name for "long-hauler" symptoms). Fortunately, with immunomodulators like leronlimab, we are now successfully able to address this problem."
ALL IMO.
That's a real good question! Plus I have to give credit to current management in that they genuinely appear to want to help patients. So not only a company that could afford a buyout, but also one with the same commitment to treating/curing.
But once a company is on the map, it's a whole different ball game.
IMO
This was an extremely helpful and insightful article.
Given NP's tendency to be the salesman and that this would be CYDY's first approval, I can totally understand why the FDA would want to see the data first and gag any communications to the public. For a life-saving drug, it would be terrible to public confidence if the FDA had to "clarify" or issue a warning against a CYDY PR based on the complete data. Better for the FDA to approve all PRs now before submission.
I still think we crushed the primary endpoint and that the 42-day or 60-day mortality doesn't really apply to us but is statistically informative in order for other drugs to reach stat sig.
Personally, I'm past the "if" we met our primary endpoint and onto thinking if a buyout maybe in the works. I would prefer a partnership, but as much as I appreciate management taking us this far, I believe the other indications would be addressed much faster with a more experienced and optically pleasing company with vast manufacturing resources. Typically, such negotiations are in the works before results are released, but who knows.
All IMHO of course, but curious what other's think.
I know correlation doesn't equal causation, but wow! Twenty percent of adverse events resulting in an emergency room visit seems a lot.
One-Third of Deaths Reported to CDC After COVID Vaccines Occurred Within 48 Hours of Vaccination
ALL IMO
I get that.
Through the weird way my mind works, I was thinking of cocktail without my finger on the actual word "cocktail." Your first response confirmed my suspicions. Even though the FDA's revised guidance today doesn't address our situation directly, I think the principles mentioned indicate the direction the FDA may take with us and are currently part of the negotiations.
All IMO.
For an approval maybe, but not for EUA. To clarify, I'm imagining LL as part of combination therapy or antibody cocktail such as Misiu suggested in her response. The targets are different and the roles of LL and other antiviral MABs are different. So, to me, the approach doesn't seem any different than combining Remdesivir with REGN-COV2 or convalescent plasma or any of the other combinations that are part of the SOC as a treatment regiment.
The revised guidance today, appears to be recommending smaller, less experienced biotechs to collaborate with larger ones for scalability. Therefore, I'm thinking that having one firm manufacture the cocktail is easier and a much more efficient use of the supply chain.
ALL IMO.
Thanks Misiu and Rockleo for the quick responses.
The bullet point that grabbed my attention was on page 6.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
I was thinking that perhaps the FDA wants Cytodyn to partner up with Regeneron or Eli Lily for manufacturing to meet supply.
Thanks again,
Misiu, Rockleo, Ohm, and other medical professionals on the board.
I need help processing the recently published FDA guidance on MABs.
www.fda.gov/media/146173/download
It seems that the negotiations maybe "requesting" Cytodyn to partner up with existing BP MABs, specifically ones that directly address the virus and infectivity.
I would appreciate your thoughts.
All IMO.
Thanks misiu143! You replied before I could!
Tryn2, it is a 2:1 trial. So there are 130 patients in the placebo arm and 260 in the LL arm. Therefore, 38 dying in the placebo arm is the equivalent of 76 dying in the LL arm. Since I'm predicting only 51 actually died in the LL arm, this translates to a reduction of deaths of about 33% ((76-51)/76).
I hope so too! lol!
I'm betting the database will be locked this Friday, and a PR will go out Tuesday morning (2/23) announcing the lock, mortality stats, that a request for EUA has been submitted to the FDA, that raw data has been submitted to the FDA and other health agencies around the globe, and that full results can be expected at the end of the quarter.
As far as the mortality stats go, I'm predicting 89 deaths, 38 for placebo and 51 for LL, translating to a 33% reduction in deaths with a p-value of .0166.
ALL IMO.
I found this article citing a Tufts Study:
"According to Tufts Center for the Study of Drug Development, the average time to build and release a clinical study database is more than 73 days and the average time to lock data at the end of a trial is nearly 39 days(1) – combined, this is more than five days longer than it was 15 years ago.(2)"
https://www.contractpharma.com/contents/view_experts-opinion/2019-04-22/data-management-in-the-face-of-growing-trial-complexity/
ALL IMO
Golfer, great observation! So if I understand correctly, the Tocilizumab study ONLY included what our study defined as "severe" patients and didn't include any "critical" patients. Yet, the placebo arm still had a mortality rate of 33%!
Crazyjogger, I also think that diet plays a huge role in resisting covid. Most coronaviruses are deactivated or at least weakened when exposed to a pH of 8.5 are greater. The ginger, garlic, etc. in many African and Indian sauces along with water consumption (e.g. teas) certainly doesn't hurt.
Excellent post CTMedic! I'm using slightly different numbers, but same principle.
At 50% interim, I'm guessing there were 19 deaths in the placebo arm and 26 in the LL arm. This translates to 29.2% and 20% mortality rates for each arm respectively and a p-value of .075.
At a potential 75% interim using the same mortality rates (n = 98 for placebo and 195 for LL), the p-value would be .0392.
All IMO.
Agreed.
South African variant of Covid-19 could be resistant to vaccine.
https://www.telegraph.co.uk/news/2021/01/03/south-african-variant-could-resistant-vaccine-expert-suggests/
We can expect lockdowns in various parts of the world to create additional variants that may be resistant to the current vaccine.
LL to the rescue!
All IMO.
Vaccine potentially inducing cytokine storm?
Has there been any more info on mRNA Covid vaccines potentially inducing a cytokine storm in elderly or others with underlying medical conditions? I know these groups are scheduled to receive the vaccine in phases 1a-1c.
ALL IMO
I gather your question is rhetorical, but for the benefit of new investors this goes back to Evil Rabbit's comment. It would be anyone who hasn't performed any real DD on the stock. They just know that it doubled in price within a week and googled "CYDY" to see what pops up for an explanation. If they see anything that hints at fraud, that's enough to pass, which allows the attack to be successful.
All IMO.
Besides the degree to which the FDA would politicize approvals during a world pandemic, I am surprised by the change in tone by many longs of late. Given the billions of dollars big pharma stands to lose, why wouldn’t anyone expect this to be a battle.
My one criticism against NP is that he, like most newbie CEOs with a deep technical background, believed the product would speak for itself. Therefore, all in the name of “transparency” they attempted to provide numerous “specs” and “details” instead of a prepared, rehearsed, and clear message. They also fail to realize when to say nothing at all, because that skillset is less developed. More importantly, they place overwhelming trust in the referees (e.g. government agencies) being fair and neutral because within an organization that is expected to crank out the best product.
I’ve worked for CEOs like above, trying to be like Gates, Jobs, or Musk, and they all make similar mistakes. That said, this is the boat we’re in, and so what are the alternatives for the next 3 months?
If we take the conspiracies off the table, it is quite clear that the FDA favors strategies that attack viruses head on and will reduce viral load, and that is not our (currently recognized) MO. Even if FDA officials understand our MO, telling the general public that something directly attacks the virus is likely to gain more acceptance and use among the public (and general practitioners) rather than try to explain what an immunomodulator is.
What we want the FDA or any other health agency to be able to say to the public is that “Vyrologix will prevent you from dying from Covid or any of our numerous potential indications!” This also why we shouldn’t do anything to jeopardize this message, including unblinding data and taking a penalty, particularly given that we are not cherry-picking participants and the SOC is improving.
Advocates for unblinding the data are also believing that the product will just speak for itself and ignoring all the social dynamics of governments telling the public to trust a small, relatively unknown biotech company.
Don’t provide reasons for governments to say no, whether technical, political, or otherwise! Comply with all rules and recommendations until you have built sufficient leverage before trying to circumvent any part of the process!
All IMO
Neither Pfizer's vaccine nor Eli Lilly's MAB are real threats. Pfizer's vaccine has to be store at -94 degrees F (-70 degrees C) making it a logistical nightmare.
And correct me if I'm wrong but wasn't the bamlanivimab trial ended because of lack of efficacy?
https://www.npr.org/sections/coronavirus-live-updates/2020/10/26/928072014/eli-lilly-ends-coronavirus-antibody-treatment-trial-other-studies-go-on
All IMO.
Even if you unblind the results, you will have to face the FDA indirectly.
Pursue EUA with FDA: I'm sorry we are being more stringent now that prior approved treatments are not really effective.
Ignore the FDA and shop around: Did you pursue an EUA with the FDA? Why not? Why are you circumventing the recommendations of the DSMC?
I realize that taking the penalty won't really hurt the stat sig, and I'm sure the DSMC does as well. So there must be another reason for suggesting the 3/4 interim. What if it better demonstrates the ineffectiveness of the other treatments in the placebo group?
All IMO.
Long time reader, first time poster. I agree that the results should not be unblinded now. Wait until after the election and the 3/4 interim results before revisiting that decision. The 1/2 interim appears good enough to focus on deals to ramp up production.