"I don't think MSB gets FDA approval on 3rd August unless the FDA makes a mistake on science or stats - I think those hoping or expecting are only going to get what they hope for if the FDA is essentially corrupted or doesn't do its job properly. That might happen - but the FDA did do its job properly last time and did resist the political pressure of the ODAC vote.
MSB hasn't put together enough data in the public domain (and they don't have to put it in the public domain - I'm aware of that - but I'm also aware that it wouldn't hurt them to put enough to show scientific credibility and statistical credibility if they had it to do it anyway - so I'm confident they don't) to demonstrate that the one phase 3 trial in children had consistently potent product uncontaminated by potentially confounding other components. If the FDA is swayed by politics or special pleading - medicines will be the worse for that.
A lot of holders (of MSB) will cheer if MSB gets approval (for pediatric GvHD) when they don;t have the data to support that - but a lot of folk will turn out to watch the fireworks when the world or their city burns too. They won't connect the consequences as being in the net to their detriment."
Cynata hit 11c today. Single digits look inevitable.
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