Article on VERU talks about CytoDyn...
"Well, renowned COVID-19 expert, Eric Topol criticized the results in the following retweet from the New York Times. His contention seemed to be based on the size of the study. No other small biotech has gotten an EUA with such a small sample. Typically the FDA needs to see 400+ patients in a phase 3 clinical trial. Veru is far short of that and follows in the footsteps of other biotechs like CytoDyn Inc. (OTCMKTS: CYDY) which achieved 82% reduction in 14-day mortality (p=.029) in critically ill patients who took a subcutaneous injection of leronlimab. Leonlimab has a much better efficacy profile and more patients (309) than VERU’s sabizabulin, but didn’t receive an EUA. The best comparable to sabizabulin, however, is Tollovir™, manufactured by Todos Medical (OTCMKTS: TOMDF) which had a 100% reduction in mortality in severe to critical patients and reduced time of hospitalization and progression to a ventilator. For comparison purposes, the placebo group in leronlimab had a 24% mortality rate for severe to critical but they did not age stratify properly. The placebo group for Tollovid had a 22% mortality in severe to critical. In the active arm of Veru’s Sabizabulin phase 3 trial, the mortality rate was 20% for moderate-to-severe hospitalized COVID-19 patients. Discrepancies so far from the norm need to be explained. The theory that explains this discrepancy traces back to the enormous differences in case fatality by country.
The GILD, HGEN, TOMDF, and CYDY mortality data reconciles to real world conditions. The only thing that doesn’t make sense is: why the regulatory process wasn’t accelerated for any of the drugs besides Gilead’s on the announcement of such good data during a pandemic.
If we learned anything from CytoDyn’s mishaps, it was that even 309 patients isn’t necessarily enough for an EUA. Granted, CytoDyn had issues with statistical significance without post-hoc age stratification as their CRO failed to balance placebo and drug arms with respect to age, skewing results. However, the issues with Veru’s smaller trial, including not even having enough placebo patients to account for one per site, coupled with potential dissimilar standards of care (SOC) or patient management means that there probably isn’t balanced enrollment with respect to clinical sites and their standard practices. Also, the death rate in Veru’s trial is likely to raise eyebrows at the FDA if the company ever requests an EUA as a variety of other trials as well as academic literature suggest that the death rate for moderate to severe COVID-19 is not as high as 45%; it tends to track closer to 20%, especially ever since the SOC incorporated antivirals like remdesivir, and for critically ill patients, dexamethasone."
https://insiderfinancial.com/verus-nasdaq-ver...ua/183126/
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