Biotech Values

[gofishmarko]

>> I thought the survey was clear enough: one answer choice that enables approval for marketing immediately or with a short delay and one answer choice that doesn’t. That’s the main issue, is it not? <<

It probably was clear enough for just about everyone but me. The main issue , as you say , is whether marketing approval will happen sooner vs. later , and I suspect most people voted with that in mind.

The more I think about what the FDA might do , the more quiz answers I would need to cover all the possibilities. :)

One way they could grant approval while appearing to maintain a high standard of proof of efficacy would be to approve with a very restrictive label ( until 02b is done ) in which only last-gasp patients are listed , e.g., " Must have failed twice on taxotere and have buzzards circling overhead ". Then docs could use it off-label any way they want , and the FDA could save face at the same time.