If the SOC treatment protocol in the specific hosp
Post# of 155303
(Total Views: 650)
Posted On: 10/22/2020 6:28:36 PM
If the SOC treatment protocol in the specific hospital includes remdesivir or whatever, patient can continue to receive it when participating in the trial, as per trial protocol.
Therefore I imagine that many of the patients who are enrolled into CD-12 worsen on SOC treatments, and docs offer them an additional chance to get an effective treatment by enrolling them into the trial. (Because patients wouldn't likely opt for the drug of an unknown company when they are doing well on the treatment they already get...).
Since leronlimab isn't available outside the trial setting, patients don't really risk anything participating in the trial, but are offered a 66% additional chance of getting something effective, unless they are enrolled BEFORE they receive SOC, which, in my opinion, won't practically happen very often (not after remdesivir EUA in May at least)...
Which is why after the protocol change for CD-12 in May allowing other treatments in, JL's argument he presented on the call for enrollment problems is somewhat moot.
The compelling offer CYDY can and has to make to the sites is this: if you have severe or critical patients that worsen on your SOC treatments, you can ALWAYS enroll them into the trial to give them another chance, without harming them since it is perfectly safe and we take them all...
Therefore I imagine that many of the patients who are enrolled into CD-12 worsen on SOC treatments, and docs offer them an additional chance to get an effective treatment by enrolling them into the trial. (Because patients wouldn't likely opt for the drug of an unknown company when they are doing well on the treatment they already get...).
Since leronlimab isn't available outside the trial setting, patients don't really risk anything participating in the trial, but are offered a 66% additional chance of getting something effective, unless they are enrolled BEFORE they receive SOC, which, in my opinion, won't practically happen very often (not after remdesivir EUA in May at least)...
Which is why after the protocol change for CD-12 in May allowing other treatments in, JL's argument he presented on the call for enrollment problems is somewhat moot.
The compelling offer CYDY can and has to make to the sites is this: if you have severe or critical patients that worsen on your SOC treatments, you can ALWAYS enroll them into the trial to give them another chance, without harming them since it is perfectly safe and we take them all...
(6)
(0)