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misiu143

03/18/21 10:48 AM

#153475 RE: Dieselpro #153462

Dieselpro , when EUA given there are no longer placebo control studies allow , at least not until now..
So they will need to do a different way , maybe with phase 4 , compassionate phase..

imo..

Bill_ENG

03/18/21 11:49 AM

#153496 RE: Dieselpro #153462

The only problem I see with that, is that CD12 showed which population gets the most benefit.

Under 65 critically ill is the best condition for proving Leronlimab works.

If a conditional EUA was granted this would be where the FDA would grant it.

That is also the patient population that CD16 is going after.

An EUA would get in the way of enrolling enough patients for CD16.