Generics are bioequivalent. Not necessary exact copies. My doctor the other day stated he cannot use the generic version of his choestrol drug, because the side effects are greater. Dacogen and vidaza have some serious side effects. Sometimes hospitalization. Can you show us where you found these master files?
I appreciate your input. If a generic enters the picture, we will take a hit on shareprice. Our eyes and ears need to be watching out for this.
Here's a nice piece on generic's. Most of the article was pro generics, but they do point out this:
Patients benefit from lower costs, but a generic substitute may not always be the best fit. For one, a generic drug's inactive ingredients often differ from those of the brand-name version, which may cause allergic reactions or other problems for a small percentage of patients.
Also, patients may simply metabolize different drugs in different ways, said Sandy Walsh, spokeswoman for the U.S. Food and Drug Administration.
But in general, patients shouldn't fear generics.
"As far as the agency is concerned, they're approved to be exact copies," Walsh said.
Still, when it comes to serious medical conditions, doctors say even the slightest change in a drug regimen may have negative consequences.
Unfortunately, for we longs Dacogen loses its “protective” status this May.
While we will not feel an instant drop in revenues; never the less the market looks forward. Sadly we are not close to any new approved compound. Maybe someone out there knows a better date, but right now it looks at least 18 months out to even get a chance at one of the science projects proving out successfully!
Name the generic company? Why would you claim to be long, but think the share price is headed south. The market out there for dacogen is roughly $200M. I don't see a generic entering the picture. Just like vidaza. With the EU aml approval, we could be looking at $90M in revenues this year. But do some DD, show us a real concern. Until and unless you do research, you are as insignificant as loverboy.