Ema odd has been accomplished before and FDA odd was expected by Dr Gunzburg years ago as he stated in a old report. Drugs/treatments do not have to prove they work to gain ODD as you may well know. Anything that targets a rare disease has high potential of gaining ODD. ONLY IF IT ACTUALLY WORKS will it be a officially approved orphan treatment.
Hired doctors don't count as development in CIAB. If something they do progresses CIAB then that will be new. Same with trials. Neither prove CIAB is any better than it was back in theatre 90's.
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