Let's face it, MSB didn't listen to the FDA and were punished for it.I too thought they would get approved this time around but I guess cherry picking data and deliberately trying to push through a trial in a particular age group rather than giving the FDA what they asked for made them tell MSB "no deal".
So far IMU has made sure to listen and comply with FDA requests which has helped in being able to move forward in our trials and get new ones approved.
Moral of the story is: FDA tells you to jump, you ask how high?
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