Biotech Values

[biomaven0]

>>achieving a Phase III approval

If the drug has reasonable toxicity, the FDA will let you proceed with a Phase III. So "achieving a Phase III approval" really doesn't mean much.

There is generally a lot of discussion with the FDA at the post-Phase II meeting, but unfortunately investors are not privy to the outcome. We generally have no clue whether the FDA said that everything looks great or whether they were very cautious and critical of the Phase III design or even of the whole program.

Peter