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Subject:  Re: What is to be gained........? Date:  4/26/2007  6:13 PM
Author:  TMFBreakerTinker Number:  30802 of 97073

Devon, keep that foot out of the mouth.

Missash, believe it or not I concur with you on the science. However, as a medical treatment I disagree that it is not potentially significant, and that there is not enough science there to justify its approval and placement on the market. There clearly is. I think that anyone who says that there is not substantial evidence of its efficacy is not being honest. There is substantial evidence that it works. There is not the type of conclusive evidence that ODEC is use to.

Given all the surrounding circumstances there is no doubt in my mind that the correct and right thing to do is to approve this drug and make it available for patients. The only thing a 3 year delay does is produce more substantial evidence that there is substantial evidence that it works, or save insurance companies some money for 3 years from using a medication that does not work.

However, the substantial evidence that it works is such that there is a lot of supportive evidence to conclude that this is not a false positive and thereby what you are doing is delaying a safe drug, a potentially life saving drug, that we are very confidence (if not certain) that it works, just to move from very confident to certain.

Again, here is the cost/benefit equation given our level of confidence that 9901 is not a false positive:

If (.05 x Cost of false approval for 3 years) > (.95 x cost of withholding drug for 3 years if drug works)

That equation is accurate and quite lopsided because the chances of a false positive are quite small, the harmful effects of Provenge are quite small, the benefit of Provenge is relatively quite large, and the result of doing nothing is quite terrible in this terminal patients. Also toss in their the intangibles of the effect of R&D in the industry, and other things Mauser has talked about vs. institutional harm, or 9902B harm that might go on the other side of the equation, and it gets even more lopsided as the reasons not to approve now are almost entirely institutional and process. The substantive reasons almost all lie on the approve side of the equation.

This is what the FDA will be looking at. ODEC wants to protect the process and institution. CDER does not have the same concerns. They want to move the process forward.

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