The problem with the Allos application was they were trying to go for the heart strings vote. We received several calls to cover the comapny around that time and did some work on it as a result. Part of that was calling the company and asking why they were focusing on breast cancer instead of the much clearer, and FAR more scientifically sensible subgroup of patients who did not present with brain mets at time of diagnosis.
The answer, from then Dir. of IR Monique Greer, was they believed pressure from the breast cancer lobby would help them get the drug passed through the FDA like the lung cancer patient lobby helped Iressa get approved. It was a 100% mercenary decision she admitted had less to do with science than with politics. We subsequently declined to cover the stock and communicated the reasons why to our Subscribers.
While I abhor the conduct of the FDA during that entire panel meeting, I can't say I would have voted positively on the basis of that subgroup either. They have never been able to answer the question of why the drug works preferentially in breast cancer patients -- which is the question I would have needed to be answered if I was to vote yes.
Now if they played the science straight up and came to me with a subgroup based upon no brain mets at diagnosis, I would likely have voted yes as long as the subgruop was properly balanced between arms.
Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC
