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cabel

06/21/11 12:48 PM

#51862 RE: daBoze #51861

I agree they should at least ONE contingency plan moving ahead in parallel. It would be horrible for the pps if we did not get past the FDA so that that we can at least perform clinical trials,... once there, if the trials are successful the world will be watching so I will fear less after that.

But if we are not allowed to go forward to at least do clinical trials, or if the keep us forever in clinical trial mode,... let's at least have another plan that will be moving forward.

What solid managemnet in this situation would not have a second plan moving forward???

4theduration

06/21/11 12:55 PM

#51863 RE: daBoze #51861

Here's some current news that shows why all the ducks must be in line before the submission to the FDA - and maybe why an overseas option is in order:

Nanosphere tumbled 21% to $1.76 after it said the Food and Drug Administration will not approve its Plavix Metabolism diagnostic test until the company provides more data.
Nanosphere (NSPH -25.23%) said that although it cannot guarantee approval of the product, it does believe it can be approved. However, as a result of the FDA’s request, the company does not foresee being able to launch the product in the U.S. until 2012.
The Plavix Metabolism test is already on the market in several European countries. Nanosphere said it plans to launch the test in additional European and Asian markets by the end of the year.

Ubertino

06/21/11 1:05 PM

#51865 RE: daBoze #51861

Is there a world accepted recognition among the various FDAs? One is recognized by the others?

It would make too much sense, so I doubt it!

Which is the best FDA?

Go there first, would make sense and I fear it will be the US.