Ulysses Benjamin Dover

Updated FDA Decision Calendar: Five Decisions Before Year-End

Mikey, once again your analysis is faulty. Like Feuerstein you miss the central issue of what Polyheme is. It is NOT supposed to be a substitute for blood when blood is available (not this version anyway, butt someday), it is for when somebody is bleeding out and there is no blood available. There is a substantial need for such a product, hence why the FDA walked this product through a controversial clinical trial and now has granted fast track. To boot, the military wants this product.

The important data is NOT a direct comparison of how Polyheme compares to blood as a substitute for blood, but how close to being like blood for when there is a need for blood but no blood is available. In the prior study it was found that people who were going to die from bleeding out, had about a 70% survival rate with minimal adverse events v. getting saline. It really is simple deductive reasoning that if I am going to die from bleeding out because we can't get me a transfusion in short order and am offered a 70% chance at survival using Polyheme, I'm using the Polyheme.

This product will receive a limited approval, the stock will rise and the company will be bought by a large well funded company that can develop and market the product further. Of course, part of that deal will be Dr. Gould to get a great paying job, but that's fine, we'll see a price north of $6 (extrapolate near term profit potential just on U.S. remote location trauma usage) in 2009.