CD12 was mixed severe and critical... As far as I
Post# of 154969
(Total Views: 592)
Posted On: 03/07/2021 3:54:39 AM
CD12 was mixed severe and critical... As far as I can tell it was weighted much more in severe (less ill), which doesnt't allow for as strong a signal as critical population. LLMab arm also, by (un)luck of the draw, ended up with a larger amount of >65 year old patients.
Back when this protocol was approved, nobody was sure exactly what they should be looking for / at, so it was an uphill and semi-blind effort to begin with. All that being said, the results show fantastic promise for >65 year olds, critical and on machine assistance. Which is really what the world needs; a treatment of last resort, when all else fails, that actually works.
EUA for CD12 doesn't seem warranted as that included severe population, and we don't know what the results we're, but I'd guess there wasn't as clear of a signal as with critical. A new study, focusing entirely on critical, preferably machine assistance, should be the way forward for the US FDA. UK is a but of an unknown, and Health Canada seems as though they are leaning towards an Interim Order / emergency authorization.
Back when this protocol was approved, nobody was sure exactly what they should be looking for / at, so it was an uphill and semi-blind effort to begin with. All that being said, the results show fantastic promise for >65 year olds, critical and on machine assistance. Which is really what the world needs; a treatment of last resort, when all else fails, that actually works.
EUA for CD12 doesn't seem warranted as that included severe population, and we don't know what the results we're, but I'd guess there wasn't as clear of a signal as with critical. A new study, focusing entirely on critical, preferably machine assistance, should be the way forward for the US FDA. UK is a but of an unknown, and Health Canada seems as though they are leaning towards an Interim Order / emergency authorization.
(9)
(0)