Replies to post #110013 on Avid Bioservices Inc (CDMO)

[geocappy1]

Since it is only necessar to show safety and efficacy in phase III, it is obvious from your discussion that bavi should proceed to ph III. IMO what is sad in this debacle is the missed opportunity for AA due to losing the stat signif portion of the results.

Due to the excellent safety and if the other ph II trials show strong support, if the FDA had any gonads they would still give bavi AA with a large ph III to back it up.

[Robert C Jonson]

As noted, I would say adding a dose or two of bavi to docetaxel (if that is what happened) would likely not impact survival, meaning the 5.6 month reported survival is likely a valid number.


Thanks for your opinions and discussion, bimerkjaere. It seems, though, that if the last part of your contention, above, were REALLY likely, PPHM would not have decided to combine the control arm with the lower treatment arm.

[freethemice]

I would agree with you on these points.

[investingdog]

<<What impact, if any, would bavi 1mg MOS be if it missed one or two, etc.. doses? >>

Well, that would be hard to believe, the 1mg and 3mg doses look almost identical on KM curve. So, are you saying that 1mg arm can miss a couple of doses and still look as good as a 3mg dose and be stat sig.? It just doesn't make sense.