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Re: JTORENCE post# 24204

Wednesday, 09/30/2020 3:46:20 PM

Wednesday, September 30, 2020 3:46:20 PM

Post# of 44697
102 patients marks the threshold for INTERIM DATA analysis by the data monitoring committee (not FDA approval)

Test *may* need 144 total people if the data monitoring committee doesn't feel the data from the 102 interim patients is enough to submit to FDA for full use approval.

In lehman's terms, this 102 patient is just a look in to whether or not the drug will be safe AND effective enough to justify using it on people who have no exhausted all other options (currently, the EUA is only for use on people who have exhausted all other treatments aka "the worst of the worst")

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