what could go wrong?, page-2

1. Control arm doing as well as study arm.

- Lots of historical data showing between 2 and 5 months average, so why would the control suddenly be so good?


2. Study design flawed.

- Design approved by fda.


3. Sudden, heinous toxic side effects.

- No heinous side effects to date. HA makes the chemo not so nasty, hence more can be given.


4. Data from Eastern Europe not robust.

- The same being used as used by Abraxis.


5. Over optimistic management.

- ACL seem to have a good knowledge base now, with lots of experience.