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Biotech Stock Mailbag: Exact Sciences

Stocks in this article: EXAS SQNM DDSS CADX DCTH TSPT VNDA

For those that did miss it, check out the Web replay of Jim Cramer's Mad Money segment on Exact Sciences from Wednesday night.

One more note: If Exact Sciences was valued the same way Sequenom (SQNM) is today, it would already be a stock in the low teens. Sequenom and its Down's syndrome test get a lot of attention, but Exact Sciences is addressing a more important, unmet medical need and a larger commercial market. And Exact's colon cancer test is real, with validation data coming on Oct. 29 from the Mayo Clinic. Sequenom's Down's test, on the other hand, is still blue sky.

Thomas P. emails, "You may recall that Transcept Pharmaceuticals (TSPT) received a complete response letter last year for their insomnia drug Intermezzo. One of the things requested by the FDA was an automobile-driving test to see if there were any residual effects of the drug after taking it upon waking in the middle of the night. (If approved, Intermezzo would be the only insomnia drug taken at a time other than bedtime.) The CEO recently reported in a presentation that the driving test, at four and three hours after taking the drug, had been completed, and that the results would be released this quarter, prior to the anticipated refiling for approval in first quarter 2011. He remarked that driving three hours after taking the drug was not recommended, but that residual effects of the drug were not significant after two and a half hours. While this is not a major trial, it is certainly of importance for a timely and successful refiling. With so much else going on this month, I can understand why you haven't mentioned this to date."

I followed up with Transcept spokesman Greg Mann, who confirmed for me via email that the Intermezzo driving study was complete and that the company would release results in the fourth quarter.

"It's an interesting study design, to say the least. We believe this is the first time that highway driving results could serve as the basis of an FDA review," Mann said.

As Thomas points out, Intermezzo is unique in that the sleeping tablet is intended for people who have trouble falling back to sleep after waking up in the middle of the night. The FDA denied approval initially in part because of concerns that taking Intermezzo too late at night would cause people to be impaired the next day. That's problematic, of course, for people who may get into their car to drive to work.

I'm not familiar with the CEO comments about the results of the Intermezzo driving study mentioned by Thomas, but it will be important for Transcept to demonstrate that people can drive safely (no weaving) three or four hours after taking the sleeping tablet (which consists of a very low dose of zolpidem, the active ingredient in Ambien.)

If the driving study is positive, the next worry for Transcept investors will be guessing how the FDA reacts to the data. Will the study be enough to ease regulators' concerns about next-day impairment?

Transcept shares were trading in the $14 range before last October's FDA complete response letter. More recently, the stock's been trading between $6 and $7.

Hanne S. asks, "Can you please comment on the rumors/uptrend regarding Delcath Systems (DCTH)? What other catalysts are coming up besides the buyout rumor? Thanks for your feedback."

Last week's rumor that Bristol-Myers Squibb (BMY) was interested in acquiring Delcath for $15 a share was nothing more than trading-room chatter designed to make someone a quick buck. Don't believe it.

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