NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

It was a long time ago so many trials for pulling data didn't even exist back then, so I doubt the conversation with EC's ever even got that far.  

Someone posted here almost seven years ago something that always made the most sense to me ( below). And, on top of it we always knew the FDA won't accept EC's without patient level data.  The FDA probabaly told her to collect the data and do another trial never expecting LP would go around them with MHRA instead which, at the time, was overseen by the EMA.  

>>Sure, the hold was placed after DMC members alerted FDA to PFS futility. This was after they alerted the sponsor who insisted it continue. The procedure is invasive (leuk) so FDA did it to protect the public. The hold was lifted in effect when the sponsor asked FDA to if they called enrollment "complete" at 331. They wanted to alleve public perception for those still in the trial that had already had vaccine made and wouldn't be subjected to any fur-ther leuk. FDA allowed it.