The little biotech that could received some guidance from the Food and Drug Administration about approval for Surfaxin, a treatment for preventing Respiratory Distress Syndrome in premature infants, which affects about 120,000 babies in the U.S. each year. Surfaxin is a synthetic, whie existing products are derived from animals.

Additional clinical trials aren’t required, the company says, but the FDA, which issued an approval letter last April, wants more info about “specification and controls.” Meanwhile, Discovery also provided more data about its production facility, which experienced stability issues (here’s some background).

This all adds up to several more months of waiting - Discovery doesn’t expect to file its formal response to the FDA approvable letter until September or October, although this doesn’t come as much of a surprise. The company is holding a conference call today at 11 a.m.

But investors were upbeat. The stock was up more than 15 percent in pre-market trading this morning on the apparent assumption Surfaxin approval chances are finally improving.

[tags]Discovery Labs[/tags]