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relocatedmetsfan

01/15/20 10:19 AM

#241214 RE: Jasbg #241209

Jasbg - “with no risk


There is still risk for generics.

1) Procure enough API for demand

2) R&D for encapsulation of API

3) FDA approval (including clearance of manufacturing process)

4) Competition from other generics

5) Slow expansion of overall market

6) Actually profit on the product (sales > COGS)


There are probably others that I did not consider off the top of my head.

However, this risk is minuscule compared to the risk of R&D that Amarin went through with the risk of REDUCE-IT, as well with the recent FDA approval process.