It's Spinal Tap-esque... CYDY: Hey, FDA. Listen
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Posted On: 08/06/2020 3:57:06 PM
It's Spinal Tap-esque...
CYDY: Hey, FDA. Listen, we're struggling to enroll patients fast enough because most doctors just want their patients to get SOC. How about we pull the interim data at 180 patients?
FDA: But we agreed on 195.
CYDY: True, but why don't we pretend 180 is halfway? Thousands of people are dying.
FDA: Interim is 195.
CYDY: We understand. But that's really close to 180. If we wait for 15 more that could take weeks. What difference does it make?
FDA: *blank stare*. Interim is 195 though.
CYDY: Hey, FDA. Listen, we're struggling to enroll patients fast enough because most doctors just want their patients to get SOC. How about we pull the interim data at 180 patients?
FDA: But we agreed on 195.
CYDY: True, but why don't we pretend 180 is halfway? Thousands of people are dying.
FDA: Interim is 195.
CYDY: We understand. But that's really close to 180. If we wait for 15 more that could take weeks. What difference does it make?
FDA: *blank stare*. Interim is 195 though.
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