us epp trials - this is getting serious

Got word today that there is an FDA meeting Tuesday with two EPP sufferers.

But, from what I have heard, it appears the FDA will not allow a Phase III FDA trial this year and we'll have to wait until 2012. This is really bad news.

And this will really delay things if it is true. The US market would be delayed yet another year.

My source is the APF - and it's a damn good source - they appear to be very frustrated as well with the FDA. According to them, it looks like a Phase III US trial is not happening this year.

This is just one delay after another. I really have to question this management team's decision to delay attempting to enter the US market this long since this is a seasonal drug. Remember how long it took them to finally file the IND.

Well, I'm not sure how they can justify all the delays now. The stock price is still down, the 10:1 conversion has not from what I have seen helped at all.

And where is the cuv9900 details we were supposed to be getting.

This EPP news is about the last straw for me if it turns out to be true. EPP approval in Europe will probably come eventually, but we're still long ways off from vitiligo approval or even any kind of approval for this drug in the US - the biggest pharma market in the world.

I want to hear them justify these delays and the negative return for shareholders after all these years this team has been getting such a high salary.

Not at all happy about this. I'm glad I pared down my investment the past 18 months.