QuatRx Pharmaceuticals' ability to obtain market approval next year for its top drug candidate is tied directly to the Ann Arbor biotech firm's ability to fulfill the increasingly strict expectations of the U.S. Food and Drug Administration, an industry leader said today.

Stephen Rapundalo, executive director of Ann Arbor-based MichBio, the state’s life sciences association, said QuatRx is on the verge of a major accomplishment. But he cautioned that regulatory scrutiny could still present problems depending on future results from clinical trial studies.

A strategically methodical approach to the biotech regulatory process puts QuatRx on the verge of a federal application for its top drug candidate.

QuatRx hopes to submit an application with the U.S. Food and Drug Administration for market approval of its post-menopausal sex drug Ophena by early 2010, company officials said last week.

Still, surmounting the final regulatory hurdles could prove to be enormously difficult - particularly as the FDA tightens oversight amid pressure from Washington lawmakers.

“There’s still a lot of unknowns,” Rapundalo said. “Other companies mightier than QuatRx have fallen on the sword in these kinds of situations.”

That’s why no one’s celebrating yet, even though approval of the drug could mean dozens to hundreds of sales jobs for Ann Arbor if QuatRx opts to market the drug itself.

Drug companies aren't immune to late-stage mishaps in the regulatory process - which QuatRx has heretofore avoided.

"We still need to get all our data in,” QuatRx senior business development director Julia Owens said in a recent interview. “We’re not quite there. But we’re very encouraged.”

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