Biotech Values

[exwannabe]

NEOP: To garner approval there is no regulatory need to run a trial against the SOC.

The FDA is not tasked with determining that a new product is as good or better than existing products, just that it is safe and effective. And this is how it should be. There can be many reasons why different product exist on the market with varying effectiveness. It is up to the docs/patients to pick the right one, not the FDA.

So the fact that Lymphoseek was trialed against blue die w/o silver collide would not in itself preclude approval. If that was all of Marty's argument, it is week.

What this bodes for commercial success is another matter, and I have no opinion at all there.

Thanks for reminding me about the citizen petition, a good laugh is always appreciated.