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shadolane

01/24/22 9:27 AM

#367176 RE: rafunrafun #367175

Generics are doing what they are allowed to do wither within the rules or outside of those rules.

Our courts have assisting them in doing so.

Regarding testing of GV if and when completed and if the results show that they do not perform the same qas V who if anyone will see the results and who if anyone will care?

This isn't about making sure that generics perform the same or testing would have been required in the first place. Of course that opinion is minimized or of no consequence to those in the know...the FDA.
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alwayswatching1

01/24/22 9:27 AM

#367177 RE: rafunrafun #367175

No doubt they are gaming the system. Everything in todays environment gives them every advantage to do so. AMRN has very little chance of overcoming this as we’ve all been witnessed to over the past couple years. Life saving drug with 25% reduction in death and yet hardly even prescribed in one of the most obese and unhealthy countries in the world. INSANITY. Combo pill seems to me to be the only hope to regain sales in the U.S but time is of the essence and the great question that always lingers is can AMRN do it alone? Well we know the answer so far is a resounding NO.
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invest2992

01/24/22 9:44 AM

#367180 RE: rafunrafun #367175

Thanks for your response.
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ilovetech

01/24/22 12:15 PM

#367229 RE: rafunrafun #367175

As a consumer of Generic's, I believe they're good at replicating branded tabs, capsules etc that don't involve a sophisticated encapsulation processing method. There's a great gab in the FDA'S equivalency guidance, which obviously failed miserably in this case, which subsequently contradicts the FDA's mission to protect patients. Price is only one element, and it's not enough to sacrifice product integrity. IMO, if there was a good case for class action, this would be it.

The FDA is not a Gov't institution. It's dressed up to appear as such.

ILT