Is phase 3 data not even enough?? As mentioned, the world is in crisis and the SOC for this pandemic is remdesivir (which is basically placebo+ assult on your liver, already perhaps being assulted by the cytokine storm) and dexamethasone (which is great for reducing inflammation and no doubt saving some lives).
When millions of people are dying around the world, treatments that work/save lives must be expiteded - especially treatments that have proven to have a better safety profile than SOC and have an MOA that reduces viral load and calms the cytokine storm that ravages organs.
This drug is tested in over 1000 people proving safety (no side effects) and phase 3 of CD12 would prove more efficacy in addition to CD10 data. Is that really not enough for an EUA? Remdesivir got an EUA and it is bad for the liver, an organ with over 300+ important metabolic functions. With that, it became the SOC and got full approval. It's not proven to be any better than placebo in saving lives and even apsirin is proving to save lives for covid patients - https://www.sciencedaily.com/releases/2020/10...195637.htm .
Saving lives is what this world needs and if phase 3 proves Leronlimab saves lives for covid patients than why the need for phase 4?
If CD12 data proves efficacy at next interim analysis (on mortality, one of the hardest primary endpoint to achieve), why would more testing be needed? Especially if people are dying by the 100s of thousands with current SOC.
Starting to feel like I'm being given a path of small bread crumbs with stories of a great meal at the end of them, provided I find and eat each one.
I can already imagine a CC at the end of the next interim analysis or even in completion of a successful phase 3 "We got the best news we could have possibly received (other than getting EUA), and we excited to do a phase 4 with 700 patients. We know we will get them quicker now that the remdesivir trials are over and look fowrard to providing the FDA what they want for the EUA."
I understand in normal times trials are 4 full phases, but this is more than a rush to improve SOC and safe countless lives for an out of control pandemic!!
If this system is THIS dysfunctional I'd like to know. It's getting worse the more I learn. Please reply if you have insights about the need for a phase 4 if phase 3 shows safety and efficacy (including hitting stastical sign. on primary endpoint - mortality.
Thanks
When millions of people are dying around the world, treatments that work/save lives must be expiteded - especially treatments that have proven to have a better safety profile than SOC and have an MOA that reduces viral load and calms the cytokine storm that ravages organs.
This drug is tested in over 1000 people proving safety (no side effects) and phase 3 of CD12 would prove more efficacy in addition to CD10 data. Is that really not enough for an EUA? Remdesivir got an EUA and it is bad for the liver, an organ with over 300+ important metabolic functions. With that, it became the SOC and got full approval. It's not proven to be any better than placebo in saving lives and even apsirin is proving to save lives for covid patients - https://www.sciencedaily.com/releases/2020/10...195637.htm .
Saving lives is what this world needs and if phase 3 proves Leronlimab saves lives for covid patients than why the need for phase 4?
If CD12 data proves efficacy at next interim analysis (on mortality, one of the hardest primary endpoint to achieve), why would more testing be needed? Especially if people are dying by the 100s of thousands with current SOC.
Starting to feel like I'm being given a path of small bread crumbs with stories of a great meal at the end of them, provided I find and eat each one.
I can already imagine a CC at the end of the next interim analysis or even in completion of a successful phase 3 "We got the best news we could have possibly received (other than getting EUA), and we excited to do a phase 4 with 700 patients. We know we will get them quicker now that the remdesivir trials are over and look fowrard to providing the FDA what they want for the EUA."
I understand in normal times trials are 4 full phases, but this is more than a rush to improve SOC and safe countless lives for an out of control pandemic!!
If this system is THIS dysfunctional I'd like to know. It's getting worse the more I learn. Please reply if you have insights about the need for a phase 4 if phase 3 shows safety and efficacy (including hitting stastical sign. on primary endpoint - mortality.
Thanks
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