MSB to dispute FDA finding in Type A meeting, page-841

Fair punt.

What data do you think? Athersys? Even though it's not the same product and they haven't nailed the dose yet? Maybe they just thought "Oh well it's all stem cell related we'll give it a go it might work"

Or do you think the data from the Mt Sanai pilot study was enough? There's not really much more they can go on is there? The DSMB wouldn't have handed over their findings at 30% or 45% in the P3. Maybe they did just take a punt because the trial wasn't stopped at 45% as @reginaldp thinks.

I just think they were impressed with the gvhd data and the Mt Sanai trial. Same product both with positive results doing the same thing. So the confidence is high due to the proven results in gvhd because they had a substantial single arm trial which proved efficacious and safe.

Maybe I'm wrong. I'd be interested if someone else could point me to a plausible reason for Novartis signing a billion dollar plus deal.