No. of Recommendations: 5

Your opinion is pretty much identical to the bear opinions that the decision ain't in yet, FDA does not have to follow the committee, nothing is for sure.

Granted, even an uncontested lay up or dunk is not for sure. This does not add to how likely this unexpected result would be were the FDA to not accept the committee recommendation, going against policy statements, the recent FDA sponsor immunological cancer seminar, etc.

Not to mention that the essential question before the FDA is really this simple:

There is clearly substantial evidence that Provenge works, but not necessarily enough to establish it works. Is it worth it in terms of medical and human terms to delay introduction of the drug for 3 years so we have even more substantial evidence to establish that there is substantial evidence that it works?

That is really the only question. The safety issue is as benign as a cancer agent has ever been.

Cost of false approval * % chance approval is false <> Cost of withholding drug 3 years should drug work as 9901 indicates

The chances of false approval, statistically are tough to grasp but the FDA's statistician put a number of 1 in 40 chance. I forget if it was 1 in 40 on both sides of the distribution curve or on each side, so to be conservative lets say 1 in 20 for both sides of the curve. That = 5% chance of false approval.

.05 x cost of false approval. And the number is more likely to be .025 x cost of false approval.

That equation has to be balanced against 95% chance drug works x cost of withholding drug for 3 years.

If .05 x Cost of false approval > .95 x cost of withholding drug for 3 years, then the FDA may very well withhold the drug.

I just cannot, given all the surrounding facts, imagine a single scenario where the above equation would hold true. Can you?

Also, "mission accomplished". The sign was not put up by GWB but by the carrier crew. The sign was indicating that the carriers mission had been accomplished. And to set the record straight the military victory in Iraq was historical in its scope and efficacy. The after math is more like rebuilding Europe. Unless you want to compare D-Day and the victory up through Berlin as part and parcel of the mess that the rebuilding effort was afterwards.

See for what I am talking about.

Here is the equation again: If (.05 x Cost of false approval for 3 years) > (.95 x cost of withholding drug for 3 years if drug works)

This is the decision the FDA will make, let me know what sort of comments you may have regarding it in regard to factors and costs to be placed on each side of that equation.

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