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Posted On: 10/24/2020 8:55:23 PM
Post# of 148908
One more observation from the October 20 call.
I was really disappointed to learn that treatment arm patients were only administered two doses on leronlimab over the 28 day trial -- on Day 0 and Day 7.
This isn't a "hindsight is 20/20 comment" -- but why on earth would you design a protocol with a PE of Day 28 Mortality and only provide two doses of the treatment drug -- when the placebo arm is continuously treated with SOC for the entire 28 or 42 days?
How many fewer treatment arm deaths might we have had, if we were allowed to provide two additional leronlimab doses on Day 14 and 21? Isn't that what you would do to save a patient who was not immediately reacting favorably to your medication?
And if the trial had simply been designed in this obviously logical manner, isn't it likely that we would have nailed the 50% interim and already been approved by now?
This seems like a glaring error. And unless someone can provide a good explanation for this, then I believe we have stabbed ourselves in the foot one more time -- like including nearly asymptomatic patients in our CD10 (even though I admit that was a P2 trial).
If true, this kind of bad judgment call will cost tens or hundreds of thousands of lives -- which is a much bigger issue to me than the stock price (which in my opinion, will eventually take care of itself).
I was really disappointed to learn that treatment arm patients were only administered two doses on leronlimab over the 28 day trial -- on Day 0 and Day 7.
This isn't a "hindsight is 20/20 comment" -- but why on earth would you design a protocol with a PE of Day 28 Mortality and only provide two doses of the treatment drug -- when the placebo arm is continuously treated with SOC for the entire 28 or 42 days?
How many fewer treatment arm deaths might we have had, if we were allowed to provide two additional leronlimab doses on Day 14 and 21? Isn't that what you would do to save a patient who was not immediately reacting favorably to your medication?
And if the trial had simply been designed in this obviously logical manner, isn't it likely that we would have nailed the 50% interim and already been approved by now?
This seems like a glaring error. And unless someone can provide a good explanation for this, then I believe we have stabbed ourselves in the foot one more time -- like including nearly asymptomatic patients in our CD10 (even though I admit that was a P2 trial).
If true, this kind of bad judgment call will cost tens or hundreds of thousands of lives -- which is a much bigger issue to me than the stock price (which in my opinion, will eventually take care of itself).
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