Hepion Pharmaceuticals Inc (HEPA)

[BooDog]

Excellent point Giovanni. Companies apply for fast track designation, along with breakthrough and orphan. If granted it can add exclusive marketing rights and give them a little more attention with the FDA.

But, none of it matters if the drug crashes and burns. That's why I mentioned just getting the fast track designation, while it's a good thing, it's not really a money maker. The science and company fundamentals are what counts. But, I'm thinking we'll have more confidence in HEPA's CRV431 as they move through their larger phase 2b trial.



Here's some more info on FDA designations
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies


Always good to see you Giovanni. You always keep things real.

Message in reply to:

What percentage of fast track drugs get approved?
In contrast, fast track status has been conferred on 1,388 drug programs since the program was established by the 1997 FDA Modernization Act (FDAMA), according to BioMedTracker, and has resulted in 258 approvals – only about 20% of the designations. Negative outcomes also differ between the pathways.Apr 16, 2021