NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

The evidence of a benefit was sufficient to justify a more thorough review. The phase 3 trial offers little in saying DCVax does NOT work. So compassionate use is a reasonable thing to allow here.

But the phase 3 trial also has some serious issues that may not be surmountable. That can be true at the same time that they would accept the application. Look at Urogen’s FDA application and their issues leading up to approval.

Longs here would be saying that the FDA would never have accepted Urogen’s app if they had an issue with the trial design (which they very much did)