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Posted On: 03/31/2020 3:09:06 PM
Post# of 154091
Re: Evil Rabbit #24361
Admittedly, I haven't read up enough on things, but ... I would be shocked if there is a placebo arm in the SEVERE trial. Remember, there are two trials, and the one approved today is not the SEVERE trial (IND to be filed, I believe).
I would also be shocked if, in the mild/moderate symptoms trial, there is not a protocol requirement/option to receive the drug if placebo patient progresses to the point (i.e., SEVERE) that they would need the drug.
I expect the mild/moderate symptoms trial exists, in part, to help rule out the placebo effect on immune markers without jeopardizing people's LIVES (like you would in the SEVERE trial if placebo was used).
Will be interesting to see what the endpoints of the trials are ...
Just my two cents.
I would also be shocked if, in the mild/moderate symptoms trial, there is not a protocol requirement/option to receive the drug if placebo patient progresses to the point (i.e., SEVERE) that they would need the drug.
I expect the mild/moderate symptoms trial exists, in part, to help rule out the placebo effect on immune markers without jeopardizing people's LIVES (like you would in the SEVERE trial if placebo was used).
Will be interesting to see what the endpoints of the trials are ...
Just my two cents.
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