It's not BOT content but just to clarify
Facts:
- MSB has the SAME product Already Approved in...Japan! (YIKES)
- FDA required greater clarification of MSB's "assays" before any further human trials would be green-lighted! [the FDA have now acknowledged - MSB improved the assays as requested]
- FDA inspected and found NO material negatives with MSB manufacturing!
- Drs will not perform trials on kids where the alternate to treatment is DEATH (not just more acne)
- MSB were only seeking a treatment aimed primarily at dying kids! That the FDA's own cexpert panel 9/1 voted FOR!
- FDA Accepted MSB's BLA Resubmission as complete!
The purpose of all this - let's hope BOT Soar - I'll retire - but NEVER assume anything with the FDA!
Ann: Appointment of Dr Howie McKibbon as CEO, page-59
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