December 2, 2011


How likely are the trial design features noted by Dr. Jen in Maxim Group's update (below) to be the final design features?

What do you think?
  • Patient population: Those with Stage IIIb, IIIc*, Stage IV M1a, and possibly some with Stage IV M1b;
  • Primary endpoint: A modified PFS;
  • Comparator: DTIC or TMZ; and,
  • Patient number: 300
In November 2010 (after the 1st meeting with the FDA in April), during a presentation by one of the company's principal investigator, Dr. Agarwala, we saw this:

In June 2011 (after the 2nd meeting with the FDA in March), during another presentation by Dr. Agarwala, we saw this:

Together with the FDA, management appears to have successfully achieved the trial design they have desired from the very beginning.

* Dr. Jen should have mentioned Stage IIIc as well. The range in the company's investigator's presentations, such as Dr. Agarwala's above note Stage IIIb-Stage IV M1a, which would include IIIc.

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