Cytodyn Inc (CYDY)

[kgromax]

My analysis of both Cytodyn points reaches the opposite conclusion

(1) Probability that the trial will be successful (statistical power)

Refuting claims of low power, a colleague handles stats just fine - he back-calculated (if I recall) initial 80% power against low-30%s death reduction to 90% against high 30s.

I found back his analysis, the numbers seem close to my own calculations and were certainly not the ones you wrote: 80% power was for high-30%s mortality (above 35%). Around 35% it dropped down very quickly, making the trial a very probable failure below 35%.

(2) LA hospital death rates

First LA is only one participant in the trial. There are 17 other participating centers. They do not face the same issues and also contribute a significant number of patients to Cytodyn's trial.

Second, a closer analysis of the statistics from the article you posted indicates that most November/December/January statistics are distorted by the patients volumes: most of the volumes occurred starting in December, not before. So that's really what happened starting in December that counts, the precise moment where hospitals became saturated. Zooming there, the LA hospitals and ICU bed capacity started saturating only around December 15th. When Cytodyn's trial enrollment had been already completed...so no issues for most enrolled Cytodyn patients, they had proper beds and standard of care. We can even go back in time to be safe. It is possible because during December 10th 's conference call, Nader Pourhassan (CEO) disclosed the enrollment rate in the very last weeks: 5 patients a day. That means in December Cytodyn recruited at most 75 patients. Let's be generous and consider half of these came only from LA and not from any of the 17 other study recruiting centers. Let's be pessimistic and assume they did not have the best bed or standard of care or had higher criticity. Let's assume their mortality was doubled on average compared to "standard" trial patients. Even under these extraordinary assumptions, the trial average SOC mortality would be stuck below 28%, making the trial a failure. You could extend further these pessimistic assumptions (more patient, higher mortality) and still be far from the threshold required.

Last, your source also proves that a previous poster's calculation that Los Angeles had >30% mortality over this timeframe in its hospitals was wrong. Your source indicate this is at most 23% at the peak. There are other ways to prove that it is wrong, for example by comparing ratios computed by the other poster to what they were in August: his calculation method also gives a 30-32% mortality for August, no difference to what he computed in December. For a period where we know it was certainly not that. This shows his data source numbers could not be reliably divided one by the other, different scopes, different methodologies.

My conclusion is that the new COVID wave helped Cytodyn enroll patients (otherwise recruitment would still be ongoing) but, fortunately, these patients benefited from a "standard" standard of care. Consequently, combined death statistics disclosed by Cytodyn make this trial a very probable failure.