orphan drug status

Zann, I see the report you quote says:

"An advantage for PRR in terms of the FDA approval process is that ovarian cancer is an orphan drug designation."

It makes sense that the diseases are designated and then any drug treating them would proceed on the orphan designation basis.

This would make more sense than to separately assess and keep re-assessing every rare disease each time a treatment were proposed for it - although perhaps they run the figures to see it hasn't become more prevalent.

Also, the Orphan Drug Act was amended in 1988 so that the orphan drug status designation had to be applied for before the New Drug Application.

Approval for the FDA trial is the important thing we hope to be announced on Friday.

Even though most of us following it on HC are used to the idea, and are mainly keen to learn the trial parameters and so on, nonetheless it is a pivotal event that will attract favourable coverage and logic compels some sort of comment or comparison in the coverage to the Dendreon story with their product in the same family.

I wouldnt be surprised to see quite significant SP advances in the next few weeks.

Approval by the FDA for investigative trial is a tremendous achievement and it provides a far more tangible basis for investment.