Seelos Therapeutics Inc (SEEL)

[Dimitrios George]

Each country must approve individual labeling. That is what is happening now. Six approved, four to go.

Countries will begin launch as the companies are ready, which of course means that they have completed whatever launch preparations they have AND the product has been delivered. It is assumed by several of us, and we think the company, that Takeda will launch first as the UK was in the early August approval with Sweden. So, in answer to your question, they are not waiting for all to be approved as each country will independently market through their licensee.

France was unpartnered and France is known to have a big alprostadil market for ED already. So partnering France was a big deal. France is expected to give national phase approval either in the next four weeks or shortly thereafter.

It looks like it will have taken about 6-8 months from general approval to national phase approval to actual launch, assuming at least one launch commences in Q1 2013. I suspect one could not shave too much off that schedule.