NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

You may be right, but if that were the case, I'd think that knowing what they already know about the trial they could submit a criteria that they were absolutely sure they would beat. If the FDA had qualms after they proved they beat it, they'd answer that they had accepted the criteria. I suspect the FDA doesn't want to make it that easy for them.

I believe we've all seen the FDA delay the approval of drugs that ultimately became blockbusters. Without a partner they know companies like NWBO can hardly afford such delays so their action often push companies into partnerships made out of weakness, rather than strength. BP wins by waiting out the process with the cooperation of the FDA.

NWBO's should be in a strong position after top line results are revealed, but they'll be weakened dramatically if there are delays before a BP partnership materializes, or the drug is approved. Clearly substantial additional funding will be needed for further trials, if it's not from a partner it would have to be dilution, but hopefully at a dramatically higher price.

Gary