But it is luck. Scenesse was approved under exceptional...

But it is luck. Scenesse was approved under exceptional circumstances. Scenesse has no competition for EPP. They have spent no money on promised business opportunities thereby showing a nice bank balance while squandering their first mover advantage. They are racing to get adolescent EPP approved to extend their market exclusivity by another year. Variegate porphyria is being developed through a small trial whereby the market was not even notified when the trial was first registered. The XP trials when they first got underway were modified to include MED as a measurement of DNA damage, the idea being that you can easily show dna damage or lack thereof by how much time it takes till MED occurs. That was a fundamental mistake in which they did not think to include that in the first XP trial. Presumably they thought about the design of the trial for a while but still missed this key detail when it got underway. This was followed up by an in-depth spiel from Clinuvel about how the US is starting to recognise MED as a legitimate DNA damage marker. Oh no shit Sherlock? Whoopsy better include that in the next XP trial!

So luck is very much part of the DNA at Clinuvel, let's hope they make their own luck from here on out!