Biotech Values

[mcbio]

Re: NFLD

http://biz.yahoo.com/bw/081230/20081230005049.html?.v=1

Not Dew, but I was a bit suprised to see that the filing was accepted and indeed is getting a priority review. However, I wonder if this is just a case of where the FDA doesn't need much time to review the application because of its strong stance against the trial results (safety and efficacy issues) and will reject PolyHeme anyway. Although if that were the case, I would think the filing wouldn't have been accepted in the first place.

I haven't kept up with PolyHeme too much of late and I see that NFLD is trying to get PolyHeme approved for instances where "blood transfusion is indicated but red blood cells may not be available, appropriate, or acceptable." PolyHeme clearly has issues compared to conventional hemoglobin but perhaps when that is not an option, the FDA will allow for approval of PolyHeme. I would still wonder how big the market would be though. Notwithstanding, I wouldn't want to bet on the drug or NFLD given the negative trial results and the fact that PolyHeme is NFLD's only drug under development.

Feurstein of TheStreet.com has wrote several interesting negative articles over the years questioning PolyHeme.
See: http://www.thestreet.com/story/10409818/2/feuersteins-biotech-stock-mailbag.html
There are links in that article to prior stories and they make for a good read.