“And instead, what they said was ‘no, we’ve thought this through, and you’ve convinced us that the clinical data are very strong’,’’ Prof Itescu said.
“You’ve got enough to get approved for children – go ahead and file, and then consider how to take the product into adults.’’
Although it is easy to claim the journalist misquoted you, these are some strongly worded (supposed) direct quotes from the CEO …. I am guessing the FDA is ok with him making these claims / divulging FDA comments ? Seems to ooze confidence and certainly holds the FDA’s feet to the fire now … Good luck to us all and as for the ambulance chasers - have a great daylol
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