David White

Updated FDA Decision Calendar: Five Decisions Before Year-End

About 5: You may be correct in your overall statement here. However, you are citing information about all pooled studies, not about this particular blood substitute. I would be more interested and more persuaded by information about this substitute in particular. The FDA did grant NFLD priority review status for PolyHeme yesterday (or at least it was announced yesterday). Also there are many times hospitals that are low on blood. There are also many operations in which there is a very low possibility of heart related problems. The blood substitute could be used in low risk cases, while the whole blood could be reserved for high risk cases. This would greatly reduce the likelihood of problems. Also it might go a long way to solving the blood shortage problem experienced by many hospitals.

As a second point, we would not have airplanes now if someone wasn't willing to take a chance on the early, very questionably safe planes. I have not heard that PolyHeme is particularly dangerous. It seems likely it is more dangerous than I had thought. However, one does expect progress over time. Using generalizations to bad mouth PolyHeme in particular seems less than fair to NFLD. If you have information specific to PolyHeme, I would be very interested to hear it.

It does seem that there will eventually be a blood substitute. Perhaps PolyHeme will be the first. However, saying "space flight to the moon or to Mars" is impossible is simply recalcitrant thinking. Whether or not you are eventually correct about NFLD as an investment, specific information about the specific company and the specific product is always preferred. To completely deny a company's invention by generalized inuendo (even from JAMA) is unthinkable. Again if you have specific information about NFLD's product, please present it.