Dear all,
Would not assume the expected date will definitely provide a definite answer. From my miniscule holdings in other Bio's (probably VLA) I seem to recall that while the FDA have to respond within a certain period of time this can simply be a request for further info.
Do not get the impression they simply ask questions to give themselves more time. Decision will come in the near-ish future but would not bet the house on any given expected date.
Have a magnificent day.
KMS
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