Adding an accelerated Phase 2 trial will not only increase the amount of data points available but enable the Company to do a dose smaller and cheaper Phase 3 than initially...
I believe that this is still true.
The most important change in the trial strategy that I can see is that now the trials seem to require actual efficacy testing whereas in all past discussions with the company there has been an insistence that efficacy testing was unnecessary since oxycodone was a known quantity. I have been told that all that would be necessary is to demonstrate serum concentration in the therapeutic range, and I believe that this message was also contained in various ASX releases.
Now, however it seems that there will be trials to determine actual pain alleviation. This is a steeper climb since the trial criterion has changed from objective to subjective.
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Ann: Phosphagenics Pain Program Update , page-43
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