Thanks to Mantsticbaby having raised a question via email to Avita, we now know that Avita has been in discussion with FDA about the original requirement of 106 patients needing to complete the Phase III study. And, shareholders may also be aware that most US Gov't agencies have been closed due to a recent budget debate and impass. But this note is simply to say that the FDA department with whom Avita is in discussion is not closed. They are funded by fees paid by applicants (remember the AFIRM grant of $1+ million)and so FDA is open and is not holding up the Avita Phase III study and the impass will have no negative effect on Avita's phase III work.
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