On ODD timing from FDA ...
1/ Initial ODD filed early November ( don't know the exact date - release said filed early November )
2/ Feedback, more data required - 29th January
~ 80 days had passed
3/ Re-submission made 14th March.
4/ 90 Days = 2nd June
I'm assuming that is the very latest ..
80 Days would be around 23rd May.
"The FDA has provided PharmAust with a pathway to address the absence of clinical data by submitting an amendment to the ODD request rather than reapplying with an entirely new application".
From the ASX release on request for more info. I read that at the time to mean it may be less than 90 days.
Since then all company representatives have towed the line at 90 days from 14/3 - perfectly understandable messaging given the critical nature of the announcement.
HOWEVER, in my mind, it could literally be any day now.
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- The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst
The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-1285
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