It has been four years since Docetaxel finished it's (very long) phase 1 trial and moved into phase 2. Four years for the phase 2, so far. If they cannot follow a 505B2, how long will a phase 3 take? On drugs that already have FDA approval, albeit some with blackbox warnings. I have friends and colleagues who could benefit from DEP right now.
Talk about multi- billion dollars deals, and holding on just a little longer make you sound like JF wielding her carrots…
DEP phase 2 trials - patience required!, page-4
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