Replies to post #293511 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

It's true that their assertions certainly support that premise.

There is no way they would know. It’s blind. They would not be informed. It’s not possible and it would ruin the trial for them to know anything.

[biosectinvestor]

It’s a mystery for a reason. And we’re it not a mystery, why then we would know, and it would be a bad reason.

[flipper44]

They are not supposed to know, correct. Blinds are rarely perfect. The FDA understands in cellular therapy trials, it’s much harder to have a perfect blind. Add to that a crossover, and the difficulty maintaining a perfect blind is understood to be quite difficult. That said, Les and DI would be the least likely to have any inkling regarding what regulators and the CRO were grappling with. Maintaining the blind to the extent possible would have been paramount. However, if randomization ceased at 300 enrolled for ethical reasons, the preservation of a perfect blind would be even more difficult, but the fact that the public is still in the dark is a good sign. Most blinds are not perfect, and the regulators know this. It could be one reason they went out to five years is because that took away the potential to time earlier locks to fit any curve separation sweet spots from anyone’s hands.

[exwannabe]

There is no way they would know. It’s blind. They would not be informed. It’s not possible and it would ruin the trial for them to know anything.

Had this actually happened the information was available. They are still blinded and know of the imbalance now, so they could have known when it happened.

Regardless, the FDA does not run the trial. They inform the sponsor/investigators what they can or can not do. The method for doing this is spelled out in law.

Furthermore, the FDA does not have any control over the sites in Germany, United Kingdom and Canada.