Biotech Notebook: Vertex, Medicines Co.

Vertex shares traded up 2.5% to close at $33.06 Monday -- a somewhat muted response to great clinical data that, I suspect, is tied to doubts about Vertex's ability to seek early approval for telaprevir.

There can be no complaining, however, about the performance of Vertex shares over the past few months. The stock has more than doubled off its March lows in the $15 range, demonstrating once again how volatile Vertex -- and hepatitis C stocks in general -- can be.

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Speaking of FDA filings and drug reviews, The Medicines Co. (MDCO Quote) is keeping mum on its effort to seek approval for a acute hypertension drug Cleviprex. The company has chosen not to disclose its so-called "PDUFA date" for Cleviprex -- the deadline by which the FDA must issue its approval decision.

Last September, The Medicines Co. announced that U.S. regulators accepted the Cleviprex filing for review, but since then, the company has maintained radio silence on the subject.

If the FDA accepted the Cleviprex filing in mid-September, the Medicines Co. likely submitted its application in the middle of July, since the agency usually takes two months to accept or reject such filings. Assuming a standard, 10-month review period would put the Cleviprex PDUFA date in the mid-May time slot. (Make that late May or early June if you want to be even more generous to The Medicines Co.)

It's June 10, so why hasn't The Medicines Co. given us any word on the FDA's Cleviprex decision?

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