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cowboyd

01/13/04 1:10 PM

#11296 RE: mjam #11264

Mjam

I doubt if there are any legal preventatives to prohibit DNAP from wearing both hats but I think there are many practical ones.

Let's role play for a second. You have developed a new drug with tremendous potential to address a wide spread malady and if approved will generate staggering financial rewards. At the same time you are working on this application several other competitors are working for the same goal. In the final analysis the first one to pass the FDA approvals will have a huge market advantage and maybe a technical one.

The FDA now mandates genetic verification for all applications in this area and it just so happens that the preferred or better stated most acceptable documentation for these approvals is being done by one of your competitor's testing divisions. How much confidence will you have in turning over all your development data to the competing company no matter how many assurances that the testing division has no contact with the development division. At best this is extremely uncomfortable and I think the FDA might in fact recognize the potential for conflict and specify that verification organizations can not be part of development companies even if they are separate division.

All the above JMHO and worth what you paid for it.

cowboyd