Delcath is expected to seek approval for its liver cancer drug delivery system with the FDA in the current quarter. Figure a six-month review period from the filing date, which translates roughly into a mid-2011 approval decision. You can also expect the FDA to convene an advisory panel to review the Delcath system, date to be determined.
I continue to believe that the data from the pivotal phase III study raises questions about the approvability of the Delcath system, and even if approved, the commercial market for the device is very small. Delcath is fully valued in the mid-to-high-single digits.
Bob P. writes, "Thanks for your short but to-the-point outlook on Vanda Pharmaceuticals (VNDA - Get Report). But you have to admit something is going on. With the stock trading at cash, the last couple of weeks have added about 33% to the stock's value. Any chance you would talk to management and reconsider? If investor relations doesn't want to speak with you, don't feel bad, I can't get through either."
Bob's referring to my sarcastic remark last week that the slow launch of Somaxon Pharmaceuticals' (SOMX) sleeping pill was making the combined Novartis-Vanda marketing effort for the schizophrenia drug Fanapt look absolutely rocket like.Vanda shares have moved from $6.50 to 8 in the past two weeks, but that's nothing more than overly optimistic buying from retail investors desperate for an improvement in third-quarter Fanapt sales. Fanapt precscriptions are growing week over week, according to data collected by IMS Health, but the overall scripts and market-share figures are still tiny compared with the competition and do nothing to reverse the reality of Fanapt's underperforming commercial launch. At the end of the third quarter, Fanapt captured just 0.2% of total market share for all atypical anti-psychotics, according to IMS data. A lot of Vanda bulls compare Fanapt's slow start to the similar slow start experienced by Pfizer's (PFE) Geodon, but c'mon, Fanapt is getting beat by Saphris and Invega, two other recently launched antipsychotics. The question Vanda followers should be asking is if Fanapt can beat Saphris, which has just 0.4% market share. Scott R. hacks at me for "being totally wrong about Vanda. You've missed this big move and will never admit you're wrong." Well, I called Vanda fully valued at $12 one year ago and that was giving the company credit for about $200 million in Fanapt sales. I threw more cold water on the stock when the initial Fanapt scripts came up lame and Vanda shares fell to $6, so I haven't missed a thing. One more item for Vanda fans to ponder as we wait for third-quarter results: What's the status of the Internal Revenue Service ruling on the tax implications of Novartis' $197 million licensing payment? Back in August, Vanda said it expected a decision in two months, which is right about now. A negative IRS ruling will force Vanda to write a big check to the government, cutting its cash cushion considerably.