WHO NEEDS REGULATORS?
You know the old Tom Lehrer’s song Poisoning Pigeons in the Park? (Or his New Math? Or The Elements? But I digress.) Well, it seems that the good folks at Scott’s Miracle-Gro have been doing that and more. It’s a very quick read – here – that reminds us that not all CEOs put the world’s interests ahead of their own.
CAMPAIGN FINANCE REFORM
I repeat from yesterday: If you can find 20 minutes, watch this presentation by author and professor Lawrence Lessig to the members of the House Democratic Caucus.
Down to $1.40 from our $1.77 purchase price, all is not lost (yet) – and Guru largely agrees with this analysis.
Suggested nearly two years ago at $2.60, and $9.30 last night, many of us have sold enough to be ‘playing with house money.’ Guru thinks it’s okay to hold for the long term.
Ouch. Down to 38 cents from $1 in April. But hang on. Guru: ‘They continue to point to the various beauty awards they have received and the number of doctors they are training (now more than 291). They continue to plan for a Phase III trial for acne (a second trial that would confirm the statistical significance in the first trial). The ‘story’ remains intact: it’s your own skin they’re using to repair you; and it can be used for a wide number of medical problems beyond acne scars. The ‘problem’ remains that sales – still unreported – will take time to develop and that the company continues to run through cash. There will have to be dilutive financings for a while. I’m not sure at this point precisely when sales take off. The company had a disaster years ago when it launched the product in the UK too aggressively, generated great sales, and then was forced to pull the product from the market because of adverse events (because it was being incorrectly administered). It doesn’t want to repeat that situation, but of course, the sooner sales increase, the sooner the company becomes self-funding. FCSC is in the commercial ‘prove it’ stage, which can be one of the most challenging for a biotech company.’
Down from $5.37 to $3.92 (oh, why didn’t I sell mine at $14! Or at least half!). Guru: ‘Reported a ‘positive’ meeting with the FDA in preparation for refiling their New Drug Application. Last year, the FDA refused to accept the application because it wanted a comprehensive accounting of all patients who had received the product. The concern was safety. DCTH infuses 10 times the approved dose of melphalan into the liver. If enough of it leaks into the body, it could kill the patient. On the other hand, administered only to the liver via the special catheters, it definitely delays progression of the tumor. No one has seen the final safety database. Presumably no news is good news. Thus, it seems likely they will refile and stand a reasonable chance of getting approval in the US. Still, we need to see all of the data to be sure. They have launched in Europe, but the European approval covers the catheters as devices for delivering drugs, but didn’t specifically approve the clinical utility in cancer. I expect if they were to get US FDA approval, they could get a clinical indication in Europe as well, but then again, funding in Europe has begun to tighten because of the credit crisis. Not sure I would count on Europe for a lot of sales one way or another.’
Down to $5.83 from $7.35. Guru: ‘Has an upcoming acute heart attack trial. Phase 2. Probably negative. However this year they file for approval for GVHD – Graft-Versus-Host Disease – and later they have data in Crohn’s Disease that should work. Will be big if it does. So hold.’