It should start when you get your last feedback. That assumes that proper paperwork has been submitted.
It is pointless to argue about exactly what the process is at this point. All we have as solid information is the old published process. If things really are changed then the rules have not been published so we are guessing and nothing more.
The company has said that an IND has been filed 6 months ago. What has happened since then has not been disclosed.
We don't know if the IND was withdrawn we the company received the genetic and biome data or exactly how that was handled with the FDA.
Nor do we know how the FDA is dealing with the new approach that AVXL seems to be pursuing.
The company has indicated that an IDN has been filed for seems to be a second time. Clint is saying the ball is in the FDA's court. Whether that means a 30 day clock has started we can only guess.
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