How about this question:
What impact do the new rule changes coming into affect in August have on the possiblity of KRN5500 obtaining orphan drug designation, as compared with under the old rules? Is it more or less likely to be granted to DARA under the new rules?
The new rules will be effective on August 12, 2013.
"Among the changes is a clarification of the definition of "orphan subset." FDA noted that some companies were, in its opinion, seeking out the narrowest possible subsets of diseases to allow them to obtain incentives like tax benefits or market exclusivity incentives.
"Use of such artificial orphan populations to obtain orphan-drug designation and its related benefits would divert resources away from research and development of drugs for true orphan diseases and conditions," FDA wrote. To that end, it said it would substitute the term "medically plausible" for a definition to stop companies from potentially ”gaming” approvals.
But that left sponsors with a question as well: What is an appropriate subset for the purposes of obtaining an orphan drug designation? Under the new definition, FDA explains that a subset is taken to mean the drug is appropriate when used in the subset, but use in a broader population would be inappropriate "owing to some property(ies) of the drug," such as toxicity or the mechanism of action.
This, too, raised a problem for sponsors, who expressed concern that they would have to prove a negative: that the drug would not be useful in a second population. FDA said that while it "understands the concern," it is more concerned about an orphan subset being "artificially narrow." It will not require the same scientific proof for the negative population that it does for the positive one."
woah ho ho ha ha hee
You say this so assuredly, based on what.....?
Over a buck.... in itself is not saying much, look at a mulityear chart to see why, also at 1.20 a couple months ago, and it is now barely a dime higher than its all time low.
although it has to start somehwere, eh.
Not that I'm complaining, but up to the close it was i believe under .74, and there were no trades or volume before the close to move the price. looks like a few seconds after the close, there were 2, 100 share lots traded at .76. funny. Now in AH there has been about 2000sh traded at .77.
The move up off the bottom is accelerating. who forgot to buy at .70 like i was big time, as posted on this board? ho ho ho ho ho ho oh oh
hahahaha hoh hoh hoh de haa
fools blown out at the bottom. woooaaaaahho ho ho ho ho