Especially if your top 30 have exercised their options and now only hold Heads...
I've asked MT why the "Supportive Information" requested by the FDA to enable them to process the Orphan Drug Designation application is going to take 2 weeks to deliver ,,,
Highlights:
• The FDA has requested clinical trial data to support the granting of Orphan Drug Designation for
the treatment of MND/ALS
• PharmAust is due to release its Phase 1 MEND Study clinical data this quarter and will submit an
amendment to the FDA following this release
• PharmAust will be allowed to submit an amendment rather than reapplying with an entirely new
application
So we know it wont be 90 days as thats a full application from the start and the regulated processing time is only 90 days ,, I figure we were 51 days in before the request ..
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