4 ms·
What's really disturbing is that the FDA has flunked Prochymal twice now (if I'm recalling correctly). Which is why Osiris went to Canada to get an approval, ho
by adventureful 14y ago
What's really disturbing is that the FDA has flunked Prochymal twice now (if I'm recalling correctly). Which is why Osiris went to Canada to get an approval, hoping to demonstrate safety and push it globally, as it's still an X factor whether the treatment will ever make it past the FDA.
Osiris even has the Pentagon / DoD in their corner (and had Genzyme as their partner for a long time to boot), as Prochymal is being developed under a government contract to treat skin radiation burns and similar. If you can't get a drug through with those boosters.......
- sp332 14y agoIt was proved safe in the US trials. It was also proved ineffective twice. That's why the FDA "flunked" it.
- ams6110 14y agoPatients were given infusions twice a week for four weeks. Soon after first infusion, 63 percent showed a “clinically meaningful” response (no further details). I am pretty sure that in drug trials, "clinically meaningful" just means it's measurable beyond the threshold of statistical noise; it does NOT mean a what most people would think of as a meaningful or marked improvement in the patient's condition
- deleted 14y ago[deleted]
- bastardsage 14y agoWhat's so disturbing about the FDA's actions? Prochymal was found to be no better than a placebo when used as a treatment in two clinical trials for graft-versus-host disease. Sounds to me like the FDA is doing exactly what it is supposed to be doing -- preventing companies from selling snake oil as a legitimate medical treatment in the US. http://www.nature.com/news/2009/090909/full/news.2009.894.html http://www.nature.com/news/2009/090909/full/news.2009.894.ht...