if they knew there were problems with recell go prior to the request from the FDA why would they even make a submission on 30 Jun at all? it makes no sense…
if you re-word the announcement it clearly says:
- AVH received a letter requesting additional data on day 90 after submission on 30 Jun.
- it will take AVH time to prepare a response
- 180-day timeline has been paused on Day 90, not reset (2 different things)
- 180-day review timeline will resume when the additional data is provided to the FDA
if they knew there were problems with recell go prior to the...
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