Replies to post #30675 on NorthWest Biotherapeutics Inc (NWBO)

[koman]

Is that LP's explanation or this MB conclusion and opinion? My apologies if this issue has already been addressed. I just thought after reading the current approved pIII design by IMUC that there is a stark difference in protocol between the two trials. If PFS was acceptable by itself then IMUC could have saved themselves at least a yr instead of the 4-5yrs it will take to finish that trial to get the final medOS data. I'll have to see how the FDA treats CLDX and their trial in GBM to see what is acceptable or not (I had discounted CLDX since I considered NWBO and IMUC technology more superior but I better do my dd on that co.) But I have been wondering where LP got this 4mth PFS advantage number. I can only think of the Avastin first line GBM trial that showed a 4mth PFS advantage but no OS advantage. Both Avastin and DCVAX-L trials are similar in that half of the placebo grp in Avastin trial got Avastin after recurrence (DCVAXL trial everyone gets DCVAXL upon recurrence) This may explain why the OS results were not significant which also may make medOS data for the DCVAX-L trial clouded at best. But the Avastin trial had both the PFS and OS as coprimary end points, and it FAILED to get approval for first line despite the 4mth PFS advantage. So why would LP focus on a 4mth med PFS number? Personally, I would want at least a 9+month PFS advantage based on the spectacular pI results, and even a 6mth advantage would be a let down, but would anyone really get that excited over a 4mth advantage? esp with a FDA that is not really investor or drug company friendly IMO. And if LP did say that was the reason for not getting or applying for an spa is to save the pII trial data of some few patients withoutconsidering that a more expensive pIII and much much larger patient numbers will be affected by that decision, then I am a little bewildered by that choice. I would have loved to see that pII trial ended early and data unblinded and then seek a pIII trial designed w/ an SPA to reduce that risk at the PDUFA date when it occurs hopefully next year or so.