Biotech-Stock Mailbag: Sangamo
06/13/08 - 06:59 AM EDT
Adam Feuerstein
Next, an email from Garey H., who writes:
Mr. Feuerstein, is there a database that a biotech investor can search to estimate a drug approval date? I can currently go to clinicaltrials.gov and see the status of a drug's clinical phase. Once a company files a new-drug application, is there a database an investor can visit to see the filing? The FDA's Web site is pretty useless for this kind of information.First off, Mr. Feuerstein is my father. Please, call me Adam. Unfortunately, there is no widely available (and free) database or Web site that lists drug approval dates. That's why I put together my own list on a regular basis. The last one I posted can be found here. If you're following a specific company and you know when the company filed its new-drug application or biologics license application with the Food and Drug Administration (typically because the company issued a press release about it), you can estimate an FDA approval date on your own. A normal or standard drug review period is 10 months from the filing date. If the drug in question receives priority review, the FDA is supposed to issue an approval decision by six months from the filing date. Companies with upcoming FDA approval decision dates include Vanda Pharmaceuticals (VNDA Quote - Cramer on VNDA - Stock Picks), The Medicines Co. (MDCO Quote - Cramer on MDCO - Stock Picks), Gilead Sciences (GILD Quote - Cramer on GILD - Stock Picks) and BioDelivery Sciences (BDSI Quote - Cramer on BDSI - Stock Picks).
Onward. Bob A. writes:
I was very surprised when you mentioned that one company's clinical trial was being conducted in Russia. I thought all trials had to be conducted in the U.S. ... My real question concerns studies done in Russia. I have some friends in Russia and I would not want to use that country's economic system for a drug evaluation. I think phase II would go very well and phase III would be very problematic. In short, the data would lead to bad investing decisions regardless of the drug's effectiveness. ... Therefore, when you report on a drug going into or having a successful phase II or phase III test would you please also mention where the study is being conducted? To me, this is important information, as I would expect more successful phase II tests and fewer successful phase III tests from Russia.Bob's email was longer, but I excerpted his main points. His concern about the quality of clinical trials conducted in Russia (or other "non-Western" countries like India, for that matter) is a valid one. Knowing the provenance of clinical data for any drug candidate you're evaluating as a potential investor should be a regular part of your due diligence routine. I wouldn't say it's priority No. 1, but it's good information to have. I don't have a jingoistic bone in my body, but I do believe, on average, that the conduct of clinical trials run in the U.S. and Western Europe is more reliable than those conducted in Russia or India or some other developing part of the world. This doesn't mean that all clinical data collected in the U.S. are infallible; heck, there are plenty of bad studies done right here. Rightly or wrongly, however, investors do look askance at companies that conduct entire clinical trials in developing countries because they believe the risk is greater that data collected there may be faulty, unreliable or otherwise not reproducible when follow-up studies are performed in the U.S. or Western Europe.
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