The P2 had a flaw in my opinion that the FDA probably would not have or did not approve for the P3. The patients started with VB-111 alone, and had a choice of crossing over from VB-111 to Avastin upon progression. Who do you think would be more likely to stay with VB-111... a patient that feels good or a patients that feels bad? That is a fundamental flaw making the results of that trial less meaningful.
I don't know if that flaw was deliberate to ensure good looking results regardless of efficacy, or whether it was simply necessary to attract enough patients for the trial, but presenting the results as meaninfull they do is misleading in my opinion.
Those P2 results do not foreshadow a failed P3... they just make it dubious like most P3's.
I don't remember if the P2 allowed patients to continue with VB-111 and add Avastin upon progression or if switching drugs was the only crossover option.
Countering this concern to some extent: Avastin is used for a lot of different cancers, just as VB-111 would be used in a lot of different cancers... if it helps. Avastin is one of the most lucrative drugs ever. It is the largest source of $ for the BP that owns it. Something that increases it's effectiveness would be enormously valuable if the patent duration is long enough to slowly feed it into all available indications.
Besides the P2 being fundamentally flawed, I am concerned that I have not seen the Ovarian P2 data. Maybe it will be PR'd today, but it was perfectly timed for an ASCO reveal, yet only P2 GBM is going to be displayed. Why? Did they do an NWBO and keep the P2 data for P3? Can they do that? It was open label... right? So... confusing to me.
News 
Market Data 
Discover 
AI
