Replies to post #188931 on Biotech Values

[vinmantoo]

{{if the FDA didn't feel that combining the corrupted Bavi arm with the supposed placebo arm to arrive at a new control arm was warranted, it's not hard to figure that they would have insisted on a repeat of PII. I expect there will be a response that says the company can do P3 if they want to anyhow, but I doubt very much that they would have in the absence of some data the FDA thought had merit. }}

Abe, you misunderstand what the FDA's role is. They aren't there to decide the wisdom of a company using their limited resources in a phase III trial rather than doing smaller properly controlled phase II trials before moving into phase III. The PPHM corrupted phase II trial for NSCLC had Bavi + Docetaxel and didn't show high levels of safety issues. Docetaxel alone is approved for NSCLC. Under that condition, the FDA won't block a move of Bavi + Docetaxel into phase III. It is up to company officials to decide whether a major commitment of limited company resources is warranted under those circumstance. A well run company concerned with increasing shareholder value would NOT push forward based on corrupted data.

[iwfal]

PPHM -

if the FDA didn't feel that combining the corrupted Bavi arm with the supposed placebo arm to arrive at a new control arm was warranted, it's not hard to figure that they would have insisted on a repeat of PII.

Not how the FDA works. The only gate they have for running a ph3 is that there be reasonably good evidence it isn't likely to hurt anyone. Beyond that the company is welcome to run whatever they want - they are just running the risk of either failing or not being adequate for approval.