@Torpy, @Mozzarc,
Not related to PAR but thought this post may be of interest. The post is titled ‘DON’T UNDERESTIMATE THE SPEED WE MAY GAIN APPROVAL’ https://hotcopper.com.au/threads/why-imu-is-a-multi-multi-bagger.5431324/page-9883?post_id=65011780
In 2021, the FDA introduced what it calls the breakthrough therapy designation (BTD).
There are currently four types of ‘expediated approval’ processes the FDA uses (that I am aware).
These include:
• Priority Review (PR);
• Accelerated Approval (AA);
• Fast Track (FT); and
• Breakthrough Therapy Designation (BTD)
If a treatment is granted all four it is called a ‘full grant’.
Leading up to 2020, fourteen drugs were awarded a fullgrant; these drugs were thought to be promising breakthrough therapies either for the treatment of a previously seldom investigated condition or with a novel mechanism and structure.
@oxxa23 I am sure you have already read this.
I am hopeful this applies to PAR and we main gain approval faster then expected.
@Outlander2 Thank you for a fantastic post and hope you don’t mind me sharing.
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