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Biotech Stock Mailbag: Exact Sciences

And besides, Clinical Data at $30 is a double from where the stock traded before Viibryd was approved. That's nothing to complain about.


@MedRedDad tweets, "I'm surprised to see $MNKD holding so well above $3.50. Any chance mgmt tries to squeeze in an offering pre-FDA meeting?"

MannKind (MNKD) needs money badly so I'm sure management would jump at the chance to sell stock. The company's problem is not supply but demand i.e. finding investors willing to own newly minted MannKind shares at the moment. Two FDA rejections of Afrezza and tons of uncertainty about the product's future don't exactly make MannKind a must-own stock these days.


Joan B. emails, "Hey Adam, now that there is nothing left for Transcept Pharmaceuticals (TSPT - Get Report) but to wait for the FDA decision on July 14, 2011, you don't need to write at length about it, I just want to know your odds about its approval knowing that all the information about Intermezzo is out, come on just state for the record your odds on this one."

You want a number? OK, I say Intermezzo, the middle-of-the-night sleeping pill, has a 65% chance of being approved on July 14. I might be willing to pump up that probability to 70-75% except the middle-of-the-night dosing -- a method of administration for a sleeping pill never before approved by FDA -- adds another level of risk.

Transcept appears to have compiled all the data needed to respond to FDA concerns raised last year. That's comforting, but then, this is the safety-crazy, reverse-course, goalpost-moving FDA we're talking about, so really, anything can happen.


Mark B. knows how to rile me up, writing, "Adam, your favorite company just issued a letter to shareholders."

Yes! The Cel-Sci (CVM - Get Report) shareholder letter, authored by CEO Geert Kersten and Chairman Maximilian de Clara, is an instant classic. Hey guys, any chance of getting a personalized copy? I'd love to frame it for my Biotech Wall of Shame.

Geert and Max devote most of the letter discussing the phase III clinical trial of Multikine in head and neck cancer patients. "We have started the study in the U.S.," the men say. Yet, nowhere in the letter does it explicitly state that patient(s) have been enrolled and are receiving treatment. "Starting" the Multikine study is OK, but certainly not as important as enrolling real patients. Has that happened yet? If so, why can't Cel-Sci simply and directly inform investors?

A quick check of ClinicalTrials.gov still shows just one medical center in the U.S. signed up to enroll patients in the Multikine study. Just one? No matter, say Geert and Max in their letter, because the phase III trial will "enroll patients from nine countries in three continents. This gives the data a lot of weight and allows us to apply for marketing approval in many places in the world."

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