Feuerstein's Biotech-Stock Mailbag

The Biotech Mailbag is open. Thanks for spending a bit of your busy Saturday with me.

This week, I'm going to respond to several letters commenting on the current uncertainty with Cardiome(CRME Quote) and the Food and Drug Administration.

"Ericson" kicks off the discussion with some kind words and a question.

"First, I want to thank you for your valuable inputs on Dendreon(DNDN Quote) last year. I made three times my initial investment and got out before the FDA's decision.

"Anyway, to Cardiome's IV Vernakalant, why do you think it's taking the FDA forever to approve the drug? The [advisory] panel voted 6-2 in favor of approval in December 2007 and the FDA was supposed to make its decision on January 19. Why the holdup? How far up do you think the stock will go once it is approved?"

I'm glad Dendreon worked well for you, thanks for the nice words. Moving to Cardiome, I share the frustration. Why haven't we heard from Cardiome about IV Vernakalant -- also known by the brand name Kynapid -- yet?

I'm writing this column on Thursday. I called Cardiome twice this week asking for an update on the FDA review. No response. Same goes for partner Astellas. I called over there, too, and also was greeted with radio silence.

I last spoke to Cardiome President Doug Janzen on Jan. 22, just days after the FDA punted on making an approval decision for IV Vernakalant, a potential treatment for acute atrial fibrilation. At that time, Janzen told me the company was completely in the dark over the reasons for the holdup, but he said the FDA had until Jan. 26 to come back to the company with either an approval or a formal announcement of a delay.

Well, if the FDA met its Jan. 26 deadline to tell Cardiome something, Janzen and the company aren't sharing with the rest of us.

Meantime, the stock slides. It closed Thursday at $6, less than half the price it was three months ago.

If anyone at Cardiome is reading this, how about saying something publicly? Or, please, return my phone call!

Now, I did some checking on my own, and here's what I hear around the biotech water cooler: There are a few outstanding questions unresolved, mainly around specific patient populations that need to be excluded from treatment with IV Vernakalant. This comes out of recommendations from the otherwise positive FDA advisory panel, and the FDA and Cardiome-Astellas are negotiating over how the exclusions or warnings will fit into the drug's label.

If this is true, it suggests that IV Vernakalant is going to be approved, albeit on a delayed basis, but hopefully soon.

Do I completely believe what I'm hearing? I'd really like to, but I can't confirm any of this, especially since Cardiome isn't talking publicly.