Timing is Everything
This type of NDA review means the FDA can take up to 10 months to make a decision (also what we are expecting for our timeline)
What is Standard Review?
NDA
What is new drug application?
This document will be the team's guiding light internally on asset prioritization and next steps
What is the run of show?
This type of media tactic is a hub housing the press release and supporting storytelling materials, including infographics, b-roll, product shots, etc.
What is an MNR (multimedia news release)?
NS Pharma's Predicted PDUFA date
What is August 31st?
PI
What is prescribing information?
This is the type of application that was submitted for Deramiocel
BLA
This type of communication is used as a company statement prior to the press release being approved for use.
What is a holding statement?
This is the day that is generally considered the day a drug receives FDA approval, and critical assets will be published
What is Day 0?
CRL
What is a Complete Response Letter?
This is the tool that 35% of journalists consider their most useful tool for generating content or ideas. It's also the first material reviewed on Day 0.
What is a press release?
This is what we should refer to the PDUFA internally and externally as.
What is the PDUFA decision or FDA decision?
This is the official type of regulatory filing that triggers a PDUFA date
What is an NDA or BLA?
ISI
What is important safety information?
True or False: There will be one long team call where everyone will stay on the phone until priority assets are live
True
The is the indication being reviewed under NS Pharma's PDUFA
What is cardiomyopathy in DMD patients?
This allows the FDA to approve a drug in a shorter time frame for serious conditions that have an unmet medical need, based on preliminary evidence
What is an accelerated approval?
PDUFA
What is Prescription Drug User Fee Act?
This is the most important thing that we at DNA can show up with for our clients and for each other
What is a positive attitude?
True or false You can only describe a drug as “new” or “recent” for one year after approval
False