[Updated: 11:45 am Eastern, 3/17/10] Who was it that once said ‘if at first you don’t succeed, try, try again?’ This Friday, San Diego-based Somaxon expects find out from the FDA whether its persistence has paid off, and whether its insomnia drug is finally ready to be cleared for sale on the U.S. market.
The FDA has a deadline of Sunday, March 21 to complete its review of Somaxon’s application to market doxepin (Silenor) to help people get a better night’s sleep. Since the statutory deadline falls on a weekend, it’s likely the FDA will send its letter to the company before the end of the day Friday. For all you antsy traders out there, it’s entirely possible investors will have to wait until Monday to hear the news (but please don’t call to ask me to speculate on the exact timing).
It’s hard to imagine Somaxon (NASDAQ: [[ticker:SOMX]]) has much steam left in its engine, but it’s still in business while awaiting this latest FDA ruling. The company’s application was delayed in November 2008, formally shot down in February 2009, and rejected one more time in December. Somaxon has burned through more than $176 million of investors’ money since it was founded in 2003, and had just $5.4 million left in cash and investments as of its most recent quarterly report, current through September 30. Still, investors haven’t given up all hope—the company’s stock has rebounded after the FDA setback in December, boosting the company’s stock to $4.05 at yesterday’s close.
I have to say this optimism struck me as kind of odd, given what the company itself said in its quarterly report about its regulatory dealings.
“The regulatory approval process is inherently complex, and clinical and non-clinical data is subject to varying interpretations. As a result, as of September 30, 2009, the Company does not consider FDA approval of the NDA for Silenor to be probable in accordance with the criteria used for accounting purposes,” the company said.
[Updated with comment from sleep researcher.] Somaxon declined a request to comment on why it thinks Silenor deserves a place on the market. But Dr. Thomas Roth, a sleep researcher at Henry Ford Hospital in Detroit and a consultant to Somaxon, explained why
