re: Ann: Clinuvel commences US Phase III tria... They're not known to.
The FDA will usually provide pharmas with a calendar date for the decision. You'll get a panel review date and a final decision date. The panel review will usually give an idea of which way the final decision will go.
However, it can get a little tricky even with the FDA approval date at times as they can sometimes slip in a decision a couple weeks beforehand and stun investors with some bad news who were holding waiting closer to the appointed calendar date. That's why many investors clear the deck about 2 weeks before the FDA decision date.
But, the FDA is much better at clarity on a decision date than the European regulators are. Playing biotechs / pharma stocks isn't recommended for those with a pacemaker.
re: Ann: Clinuvel commences US Phase III tria... They're not...
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