HDG...
I have a lot of respect for your hard work, but this is not one of your great posts.
"the basic rule that the Sonsor hasd to introduce evidence that the drug is effective and not FDA would have had to introduce evidence that the relevant drug is ineffective."
This might be the rule in Budapest, but this is not the rule in this situation.
The SPA agreement was not contingent on Amarin being able to prove lowering TGs would lower CVD risk. Indeed if Amarin was able to prove this idea, then there would be zero reason to conduct the REDUCE-IT outcome trial. When the SPA was conceived both parties understood the trig issue was controversial. There were many who felt trig lower would lower risk, many who did not. At that time the idea had enough plausibility that there were three widely used FDA approved trig lowering drugs, Lovaza, niacin and fibrates whose rationale for use was the notion trig lowering would result in lower CVD risk.
When the SPA was drawn up there was neither absolute proof, or absolute agreement that trig lowering would lower CVD, and same holds for the present. The excitement concerning V at that time was that other drugs all raised LDL-C and the FDA was moving in the direction to favor LDL-C as the most reliable predictor of CVD risk. So V would be the drug of choice, because it lowered trigs and did not raise LDL-C.
To repeat, if Amarin could prove V by lowering trigs would lower CVD risk..Then R-I would be redundant. The "new scientic issue" would indeed
in contradiction to the "Gabor Rule" would have had to prove that trigs would not lower CVD risk. Something that if the FDA could prove, would also render the R-I study superfluous.
I am not arguing whether by offering the SPA the FDA committed an error in judgement, but simply the terms of the agreement in way, shape or form indicated Amarin had the burden of proving the trig hypothesis.
Amarin is not going to take an early look at the the trial. That's far too dangerous and they risk the trial results. The FDA would be the first one to bury them and call the trial a farce.
Amarin doesn't need FDA's swift interpretation of the R-I results..That's BS. If the results are stellar they will be front page NY Times and doctors and patients will be screaming for the drug.
The company will get the label expansion and very soon..other wise the FDA's going back to court...
":>) JL
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