That "fedit" is the $64m question and getting an answer from AVH is most unlikely. There is a requirement for 106 patients to be treated and final reports for each, but my understanding is actually enticing all patients back so the studies can be completed.
The last I heard was that 80 patients had been recruited.
Would be nice to think the 12 special cases could be included in the study.
Still a long wait for shareholders.
fda, page-9
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