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Event Type
510K Submission
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PDUFA
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Phase 2a Results
Phase 2b Results
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PMA Decision
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sNDA Submission
The type of event (e.g. trial results, NDA submission, etc.)
Disease
Autoimmune
Cardiovascular
Endocrine
Infectious Disease
Neurology
Oncology
Opthamology
Other
Respiratory
The disease category from Nature Biotech article.
FDA Designation
None
Accelerated Approval
Breakthrough Therapy
Fast Track
Orphan Drug
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Rare Pediatric Disease
Special Protocol Assessment
This video http://biotechforecast.com/biotech-stock-trading-course/fda-designations-main-lesson/ explains FDA designations. Multiple selections can be made by using the ctrl key.
Specific or General Date Event
Specific Date Event
General Date Event
A radio button to indicate if the event happens on a single date like a PDUFA date or more general like Q3 for trial results.
Event Outcome
Ongoing
Positive
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Negative
Designate if the event is ongoing or has had an outcome.
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