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Biotech Stock Mailbag: FDA Playbook

In other words, having an SPA is a nice insurance policy against a company that goes all the way through a phase III study and files for approval only to find that the FDA can't use the data to make an approval decision.

Why doesn't every company conducting a phase III study do so under an SPA? Because getting an SPA is a time-consuming process and isn't always necessary. The design and endpoints used in cancer studies -- overall survival, progression-free survival, response rates -- are common and well understood, so an SPA probably doesn't add anything. (Although some cancer drug companies still seek them out.)

But if a company is developing a drug for a disease for which there are no approved drugs, or wants to use a novel endpoint, an SPA is definitely a good thing and something I look for when doing my research.

My column naming Genzyme's Henri Termeer the Worst Biotech CEO of 2009 barely generated a peep on the controversy meter. Nearly all of the email and comments I received were from people who agreed with me. Kinda strange.

Steve P. writes, " Oy Vey! Not that I would say in public, but I think you are probably right about Henri. The most efficient of all orders -- the benign, intelligent philosopher king -- always creates a big blind spot. In this case, not having strong independent thinkers surrounding him and willing to take him on may have really cost Genzyme, its shareholders and its CEO."

Roger W. also agrees: " Thanks for having the [bleep] to call out Henri for what he's done to Genzyme. He deserves credit for building up the company but his time at the top is done. Bring someone new into the CEO spot to restore Genzyme's credibility, please!"

But there was Paul, who writes, " You naming a worst biotech CEO? Ha! You got to be kidding. Get a real job, looser."

It's "l-o-s-e-r." Not "l-o-o-s-e-r." Why (oh why!) is this word so hard for folks to spell?

An email from Bruce F. " Very often, it seems that critical information about a binary event such as results of a phase III trial, or an FDA decision, leaks to some investors a day or two before it gets to the public. One can see this in trading in Dendreon(DNDN), both before its most recent phase III results, and also in the put-buying before the negative FDA decision in the spring of 2007.

More recently, Osiris Therapeutics(OSIR) (as you noted), Poniard Pharmaceuticals(PARD) (put buying) and Vivus(VVUS - Get Report) have all shown conspicuously heavy and accurate trading in advance of announcements. So, what's up with this? Who is getting this information, and how? Will the SEC ever do anything about it? If not, why not?

Leaks happen. It would be foolish to assume that they don't. Do they happen very often? I don't think I'd go that far.
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