That’s what Tim Anderson, a pharma analyst at Sanford Bernstein, writes in an investor note this morning. Although Novartis recently received approval from the European Medicines Agency (EMEA), his sleuthing indicates some European countries have the same safety concerns that have delayed FDA approval of the diabetes drug in the US. In fact, he believes Galvus may not win FDA approval.

“Our understanding is that, in certain international markets, Galvus may also now be in trouble, as it is in the US. This is presumably again due to unanswered questions about the product’s safety profile,” he writes. And then adds: “In the US, we believe the product may not launch at all given ongoing demands by FDA to clarify potential safety concerns that Novartis may find to be too onerous. We currently have no revenues for the product in our US model.” UPDATE: A Novartis spokesman declined to comment on what he termed “market speculation.”

You may recall that Novartis received an approvable letter for Galvus in February, which means the FDA is prepared to approve the drug, but some conditions must still be met. A safety study required by the FDA may delay Galvus until 2010, if the drug gets that far. This wasn’t the first setback - a year ago, the FDA delayed approval by three months waiting for more safety data after skin lesions had been seen in monkeys.

Of course, this is good news for Merck, because its Januvia is in the same new class of diabetes meds. As Anderson points out: “Any setback that Novartis faces with Galvus most immediately benefits Merck’s Januvia, which has thus far escaped safety issues of nearly any sort.” Well, almost. The drugmaker recently disclosed receiving reports that some patients developed serious complications, including a potentially fatal skin condition called Stevens-Johnson Syndrome, and serious allergic reactions. The info was added to the Januvia label.