dia,
I agree with you. Too often the discussion around here has been guided towards biostatistics, hazard ratios, stat sig, etc. While I appreciate all of this (and understand too much of it to be truly sane), I prefer the common sense approach.
FDA does not fund trials. So, if I'm the FDA, what do I have to lose to say ok to a bavi ph III trial in nsclc?
Well, I need to know that it's safe. You've addressed that in your post as have multiple additional trials. This is really my main concern. Of course I'd like to have an indication of efficacy. Check again. Even if it's anectdotal and isn't a true comparator, 3mg against historical trials with 77% improvement is extraordinary. Do I need stat sig data? Heck no. Most, and I repeat most, phase II trials are not set up to prove stat sig.
So, what could be the downside? Well, if I allow a trial as proposed, I'll be letting PPHM recruit prospective patients. This might limit the number of patients available for other 2nd line nsclc trials. And, if there are others out there showing better safety and efficacy numbers, do I want them to have to fight bavi for patients? Well, I really don't have any other trials that currently look better than bavi. So, I guess I won't be taking too much of a hit here.
So, let's see. I have an unmet need. I have a candidate that has shown safety and efficacy and has other trials data that corraborates this data. And, I don't have to pay a dime for the trial(s). And, this is just ph III, not final approval. Seems easy to me. I guess the only questions I really need to address is sample size and if I grant AA or other new designations.
Regards,
WH
