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Biotech Stock Mailbag: FDA Playbook

Common sense, right? You'd think so, but companies ignore FDA guidance all the time. [<b>Genzyme</b> <span class=" TICKERFLAT">(<a href="/quote/GENZ.html">GENZ</a><a class=" arrow" href="/quote/GENZ.html"><span class=" tickerChange" id="story_GENZ"></span></a>)</span> did this recently with its cancer drug Clolar.] Stupid, but it does happen.

Biotech and drug investors need to think about these issues while doing their research. Has a company held an end-of-phase II meeting with the FDA? If so, what was the outcome? What advice did the FDA provide for the design of the phase III study and how was the guidance incorporated into a final study design?

The FDA won't answer these questions, of course, so you need to rely on the honesty of management to provide straight-up answers. Honest management? Does such a thing exist?

Also, clinical trials don't exist in a vacuum, so take a look at how competitors or similar drugs were tested. If a company settles on an entirely novel study design or primary endpoint, different from what's been used by other companies in the past, I'd want to know why.

A Special Protocol Assessment is essentially a formal agreement reached between a drug company and the FDA that the design and endpoints of a phase III clinical trial are sufficient for a drug's approval.

Now, be careful. Do not assume that an SPA makes drug approval more likely. An SPA study can still fail or produce equivocal data that prods FDA to delay or reject a drug. What the SPA does is ensure that a company's phase III design is the right one to provide the data and answers that the FDA needs to make an approval decision.
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