pre·dict·a·ble

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.