(Total Views: 424)
Posted On: 03/10/2021 8:39:42 AM
Post# of 153822
A few lessions CYDY should learn from the past costly failures:
(1) Control your trials, control the ratio of severe vs critical, ratio of mild vs moderate, age (over 65 vs under 65 could be still not good enough), gender, what the placebo arm treatment is getting etc.
(2) Be conservative and provide margin for error. Standard of care is improving, what is statiscal significant in CD12 may not be easier for CD16, use the latest patient data not data from 9 months ago to calculate the trial size. If you always assume best case scenario, you will be always disappointed.
(3) Have the gut/expertise to push back on FDA decision. Efficacy proven in unblinded randomized test should stand on its own, exploring its MOA is not FDA's job. HIV should be approved based on its current data. Playing nice guy in this case may not always work. You will need clinical trial experts who can speak up and lawyers who can carry a stick.
(4) Provide hedging for trial failure. Don't be over optimistic about any trial. HIV BLA filing is a good hedging, uplisting is good hedging. Dilution is not so bad comparing to 50% stock price drop.
(1) Control your trials, control the ratio of severe vs critical, ratio of mild vs moderate, age (over 65 vs under 65 could be still not good enough), gender, what the placebo arm treatment is getting etc.
(2) Be conservative and provide margin for error. Standard of care is improving, what is statiscal significant in CD12 may not be easier for CD16, use the latest patient data not data from 9 months ago to calculate the trial size. If you always assume best case scenario, you will be always disappointed.
(3) Have the gut/expertise to push back on FDA decision. Efficacy proven in unblinded randomized test should stand on its own, exploring its MOA is not FDA's job. HIV should be approved based on its current data. Playing nice guy in this case may not always work. You will need clinical trial experts who can speak up and lawyers who can carry a stick.
(4) Provide hedging for trial failure. Don't be over optimistic about any trial. HIV BLA filing is a good hedging, uplisting is good hedging. Dilution is not so bad comparing to 50% stock price drop.
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