The agency is expected to bring VBLOC in front of an advisory panel during the first quarter of next year, Lea said.
I said Enteromedics is a complicated story because the company prefers to talk about VBLOC efficacy in terms of "excess weight loss," which confused a lot of investors, and even the few analysts who cover the company.
Excess weight loss (EWL) is a calculated as a percentage equal to total weight loss in the study (the numerator) divided by the difference in baseline weight and "ideal weight" using a BMI of 25 (the denominator.)
So, when Enteromedics tells investors that VBLOC Therapy patients achieved excess weight loss (EWL) of 25% after 18 months of treatment, as it did this week, this does NOT mean patients lost 25% of their baseline weight.
At 18 months, VBLOC Therapy patients lost 9.5% of their baseline body weight, or 23 pounds. The control arm patients lost 4.4%, or 11 pounds. That's a difference of 5% or 12 pounds.
It looks like VBLOC efficacy increases over time, from 12 months to 18 months. Be careful about making that assumption because the results likely overstate efficacy. The 18-month analysis issued by Enteromedics this week encompasses 159 of the 239 patients enrolled in the study and analyzed at 12 months. What you're seeing here is likely selection bias from patients who respond and continued the trial beyond 12 months. Patients who don't respond well are not represented.
David C. writes:
Arca Biopharma (ABIO) was flagged for a potential breakout. I'm wary however. I like the street articles but have found that many take stock in your opinion (pun)?
It's amazing what you find digging deep into the archives of my 13 years covering biotech stocks, like this story from September 2008 about Arca and its plans to resurrect a very old and failed beta blocker bucindolol using a genetic test to identify a subset of heart failure patients in which the drug would be particularly effective.
I was skeptical about Arca's bucindolol strategy back then, which proved to be a good call. Arca traded at $53 in September 2008, adjusted for reverse stock splits. Today, Arca shares can be bought for $1.60 and the company has only reached the starting line for the phase III study of bucindolol in heart failure.
I don't see why a dubious drug development idea more than five years ago is any wiser today, but biotech bull markets often put investors into a state of blissful amnesia. Zacks analyst Jason Napodano has been recommending Arca recently. I encourage you to read his bull thesis. I like Jason very much but I don't know if he appreciates how stale the bucindolol story really is.
One more thing: The composition of matter patents on bucindolol have expired, so to commercialize the drug (if it ever gets to that point), Arca will need to rely on method of use patents covering the genetic testing. These are the tests which Arca claims will identify just the heart failure patients who can benefit from the drug.
Just my opinion, but I find it hard to believe Arca will find a Big Pharma partner willing to take on bucindolol with a sketchy intellectual property strategy. Big Pharma makes lot of bad investment decisions but they don't usually screw up on IP.
It's true. Whenever I explain the risks involved with Keryx Pharmaceuticals (KERX) and its iron-based phosphate binder Zerenex, the stock goes higher. Keryx shares will probably rise today, too, because it's easy to kick the Zerenex risks down the road without worrying too much about getting hurt. The FDA won't decide on Zerenex's approval until next June. That's when Keryx's problems become impossible to ignore.
So, until then, you're welcome. Just don't be the last guy holding the stock. Amarin (AMRN) shares peaked on the day Vascepa received FDA approval. Keryx is just like Amarin.