From Seeking Alpha Thoughtful Investing
Here are some of my thoughts on today's Press Release about Refuse-to-file action of the HIV BLA application, lock and unblind Phase 2 mild/moderate study and Data Safety Monitoring Committee (DSMC) safety review next week.
Refuse-to-file actions are used because FDA does not want to be locked into statutory time frames, e.g. PDUFA 6 or 10 months, until it has all the information in a form that they like. Obviously, clinical study result deficiencies would take the longest to correct. We apparently don't have that here.
Lock and unblind appears to mean that they expect to have all the data from the Phase 2 m/m trial certified and reported by the end of the week so they can unblind it and begin analysis. Obviously you can't analyze leronlimab patients vs placebo unless you know which is which (hence unblinding). They will know that at the end of the week and can start to analyze the data. Clearly they are motivated to complete the analysis as quickly as possible.
When the Phase 3 severe/critical data monitoring starts next week, if there is a tremendous difference in the death rate of the leronlimab vs placebo groups, it should be "painfully obvious". I think this is bullish because the results in the prior open label 70 eIND compassionate use patients showed dramatic evidence that leronlimab was saving lives. I am not a statistician but it seems to me that if they have 120-130 patients (I don't recall the exact number) or more, the results will be clear. Thus, I would not be surprised if the DSMC stopped the trial as soon as they looked at all the data next week so all severe/critical patients can benefit from leronlimab ASAP.
I hope this does not come to pass but I would not surprised to see hyperbolic negative and factually unbalanced or outright false posts and publications bashing leronlimab to set CYDY up for more short attacks this week before positive pivotal news with respect to the Covid trials can be announced. We have seen this movie before twice during the past two weeks. So, buckle up your safety belts for a roller coaster ride this week and next until positive news from the 2 Covid blinded trials is published.
Here are some of my thoughts on today's Press Release about Refuse-to-file action of the HIV BLA application, lock and unblind Phase 2 mild/moderate study and Data Safety Monitoring Committee (DSMC) safety review next week.
Refuse-to-file actions are used because FDA does not want to be locked into statutory time frames, e.g. PDUFA 6 or 10 months, until it has all the information in a form that they like. Obviously, clinical study result deficiencies would take the longest to correct. We apparently don't have that here.
Lock and unblind appears to mean that they expect to have all the data from the Phase 2 m/m trial certified and reported by the end of the week so they can unblind it and begin analysis. Obviously you can't analyze leronlimab patients vs placebo unless you know which is which (hence unblinding). They will know that at the end of the week and can start to analyze the data. Clearly they are motivated to complete the analysis as quickly as possible.
When the Phase 3 severe/critical data monitoring starts next week, if there is a tremendous difference in the death rate of the leronlimab vs placebo groups, it should be "painfully obvious". I think this is bullish because the results in the prior open label 70 eIND compassionate use patients showed dramatic evidence that leronlimab was saving lives. I am not a statistician but it seems to me that if they have 120-130 patients (I don't recall the exact number) or more, the results will be clear. Thus, I would not be surprised if the DSMC stopped the trial as soon as they looked at all the data next week so all severe/critical patients can benefit from leronlimab ASAP.
I hope this does not come to pass but I would not surprised to see hyperbolic negative and factually unbalanced or outright false posts and publications bashing leronlimab to set CYDY up for more short attacks this week before positive pivotal news with respect to the Covid trials can be announced. We have seen this movie before twice during the past two weeks. So, buckle up your safety belts for a roller coaster ride this week and next until positive news from the 2 Covid blinded trials is published.
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