One thing the company has said is that some patients are staying on treatment longer than expected.
One thing that really sticks in my mind is the increased PFS in the phase II was accompanied by an increased treatment time with the HA-interocean treatment lasting at least twice as long (from memory and if I read the description of results correctly) as the interocean only . So it seems logical to think that the increase in PFS for the phase II might be largely due to the additional treatment time. Regardless this still achieved a good outcome of doubling the phase II PFS, although OS was unfortunately not improved.
The second thing that sticks in my mind is the fact that (again from memory) the phase II was open label. I know being part of a trail would have given some patients increased hope. Has this helped them to overcome some of the challenges of staying on chemo, resulting in increased treatment time and an increased PFS?
For the phase III we don’t know what mix is staying on treatment longer, it could be 50% from each if it is due to hope gained from being in a trial. This will be neutral to the trial outcome and may even de-power the trail if the equal numbers are staying on treatment longer are large enough.
For me the two things above are a worry, although I should also say I have no experience in bio-tech and very little experience investing in bio-tech as well as some or all the above recollections/interpretations re phase II may be in-correct.
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