having just read again the last ann re the negotiations with the FDA it looks unlikely to be a straight “no” if it’s not an outright approval. Possibly a request to broaden the study or add an extra screening stage. I think if the FDA had serious reservations about the adrenal finding they would have nixed the IND first time around rather than talking to PAR about mitigation. IMHO
Ann: Trading Halt, page-35
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