They could use this announcement for the reading and comprehension section of the next SAT test. The information that people are looking for is there, but very difficult to dig out.
Biotron sought…assurance that… [all the BIT225 clinical trials and lab tests they have done] were sufficient to support this next stage of clinical development.
[Biotron asks “Would it be ok if we skipped the phase 1 trial?”][FDA says “Yeah. No worries.”]
[FDA says “looks like you’ve done your homework!”]
[FDA says “Here, have a streamlined, thoroughlytested, phase 2 procedure to follow”]
[MM thinks “We don’t have to spend all those extra months designing the trial from scratch!’]
[At this point, MM probably went dancing around the room making rude gestures to all the naysayers.]
I know I would!
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Ann: POSITIVE FDA GUIDANCE FOR COVID-19 CLINICAL PROGRAM, page-183
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