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Rkmatters

12/20/14 5:00 PM

#27215 RE: Basin Street Blues #27213

BSB, I'm not the right person to answer this but I'll try. My understanding is that if the trial does end up having to repeat Phase III for any reason, then IMUC with their loaded antigen would move to the head of the FDA nGBM line. So in my eyes they'll be looking to avoid an error at all costs. And, since it's only an 8 month difference according to some here, then not halting and completing the trial seems to me the best way to go.
I can't answer with other examples, I don't know biotech well.

Rkmatters

12/20/14 5:18 PM

#27216 RE: Basin Street Blues #27213

Also, maybe the company issue isn't the halt per say. It could be that the company really needs more time to get the Commercialization aspect of the regulatory decision squared away. We know they're on track in Germany on that front, but we can't say for sure that they're ready in the U.S. and the UK. No sense halting until they're sure they can pass the Commercialization portion.

Ps. iPhone is changing letters to caps in the iHub app.

Pyrrhonian

12/20/14 6:17 PM

#27222 RE: Basin Street Blues #27213

I have read of multiple but forgot them specifically. Though DNDN had to run another Ph III due to FDA disliking aspects of data and Sunitinib approval was delayed for years after an early halt because FDA had numerous issues with it. I'll look up others when I get a min.