In other words, in order to show any survival advantage for Prochymal protocol 275, not only did Osiris need to employ a dubious historical control group, but it had to separate the GVHD patients by disease severity.
Osiris has never adequately explained why Prochymal benefits children with GVHD but not adults, nor has it explained why Prochymal only seems to prolong survival in children with more severe grades of GVHD while not helping less sick patients.
When Canada granted conditional approval for Prochymal in May, Osiris CEO Randy Mills told the New York Times that the company filed first in Canada because the U.S. Food and Drug Administration had told the company it would need additional data before seeking approval here.
The newly released Canadian regulatory documents show our neighbors to the North, despite approving Prochymal, are not yet convinced that the stem cell therapy benefits GVHD patients. FDA isn't going to be as lenient, which puts Osiris in a tough spot fundamentally, even if it has momentum traders on its side for now.@zortrades asks, "What is your take on $ARNA?" There's frenzied trading in Arena Pharmaceuticals (ARNA - Get Report) ahead of the June 27 FDA approval decision for the weight-loss drug lorcaserin. Take a look at the StockTwits heat map for health care: The trader twitter chatter is dominated by Arena!